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Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
DOCUMENTATION
Introduction
Document is a written report or record that provides information especially of an official or
legal nature.
Documentation is a method of preparing a written material, which describe the process in terms
of specification, instructions etc.
The drugs and cosmetic rules under the “conditions of licenses” and under schedule M require
a manufacturer of drugs to maintain various records.
The GDP can be defined as “Good documentation practice is an essential part of the quality
assurance and such, related to all aspects of GMP” this definition is based on WHO.
Clearly written documents prevent errors of various activities in pharma each and every
activity is written in specific documents such as SOPs and strictly followed. Spoken
communications may be create errors so that all important documents such as Master formula
record , procedure and record must be free from errors and Documented. It is difficult to make
a list of required documents and totally depend upon Companies activity or environment.
Followings are the activity factors considered during designing of any documents.
1. Type of formulation
2. Country requirements
3. Availability of ERP or SAP system
Purpose of Documentations
• Defines specifications and procedures for all materials and methods of manufacture and
control
• Ensures all personnel know what to do and when to do it
• Ensure that authorized persons have all information necessary for release of product
• Ensures documented evidence, traceability, provide records and audit trail for investigation
• Ensures availability of data for validation, review and statistical analysis.
Importance of Documentation
 It provides necessary working details.
 Reduces the risk of mistake.
 Help in tracing the deviation from the expected yield.
 They help in decreasing the batch to batch variation so that quality of product is kept
within the limits of acceptability.
 Considered as the history of batch operations.
 Self-inspection of procedure.
***Documentation and records are essential for obtaining accreditation, certification of ISOs
and approvals by Federal Bodies.
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
Classification of Documentation
Following are the classification of Documents
• For organization & Personnel.
• For Buildings & facilities
• For Equipments.
• For Handling of R.M.& P.M.
• For Production & process control.
• For Packaging & Labeling control.
• For Holding & Distribution
• For Laboratory Control.
• For Records & Reports.
• For Return & Salvaged finished products.
Type of documents used in pharmaceuticals
1. Specifications: as per MHRA Specifications describe in detail the requirements with which
the products or materials used or obtained during manufacture have to conform. They serve as
a basis for quality evaluation. We need specification for:
1. Active and inactive materials
2. Primary printed and packing materials
3. Intermediate and semi finished product
4. Finished product
2. SOPs: it is a written, authorized functional instruction used as a reference by the person
responsible for performance and are also used for training new operators in the performance of
the procedure.
3. Test method: it is a written and approved documents describe the detailed testing
procedure.
4 List: Documents contain a catalog of any object such as list of equipments.
5. Certificates of Analysis: it is an authentic documents shows the analytical reports and
decision of acceptance/rejections
• Label
• Records
• Organ gram
• Job description
Batch Manufacturing records:
It is an important document issued for every batch of product to assure, review and record
keeping of any product batch. There are following major content of BMR.
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
1. Name of product, generic name, strength, shelf life, manufacturing date and exp date.
2. A complete list of ingredients with full description, codes and quantity to be issued.
3. A statement for theoretical yield and reconciliation.
4. A complete MFG and control instructions, sampling and testing procedure, specification and
precaution to be followed.
5. A statement for processing location and equipment.
6. The method or reference to method to be used for preparing the critical equipment including
cleaning, assembling, calibrating and sterilizing.
7. Dates and time of all activities
8. Line clearance procedure in every steps
9. Labeling control and specimen for coding in primary, secondary and tertiary packing
materials
10. Deviation record
11. Result of examine made.
Preparation, issues and uses of Documents
Documents should be carefully and logically specify to prevent wrong uses. All necessary
information’s are written unambiguously. Each document includes:
1. Company name
2. Purpose and title of documents
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
3. Identification No and revision No.
4. Date of authorization
5. Date of review
6. Signature of prepared by, checked and authorized by.
7. Distribution list
8. Page no.
9. Reason for revision should be documented.
10. Abbreviation and reference
Each document is clear and computerized so that it is readable, issued documents signed by a
concern person to indicate a verified issue. Any correction is made by cutting with single line
with signature and date, do not overwrite. Document to filled have a sufficient space, ball ink
pen should be used for hand written filling.
Document control
The process by which a manufacturer ensures that all procedures used and documents
generated in G.M.P. – related actions are current, accurate and approved.
Purpose of document control to control issuance, possession, use and revision of master
documents including
Standard Operating Procedures
Data collection forms
Validation Protocols
Master formulae
Batch records
Function of Quality Assurance Unit
Initially document is prepared by concern department as draft and draft is reviewed by dept.
head and final draft is send to QA department that convert a draft to a final documents checked
and approved by authorize person. Control copies are issued to concern department and
issuance records are maintained. After approval of documents such as sops quality assurance
must ensure that all users/concerned department gets training before the implementation of the
sops record of such training must be maintained. A training co-coordinator preferably the head
of user department or any designated individuals shall be responsible for organizing the
training. After successful implementation of training on any sops, the sops become effective.
Original sops are stamped as “MASTER COPY” with red ink, master copy are stored under
supervision and photocopy of master copy duly stamped as “CONTROL COPY” in blue color.
Sops distribution list should be maintained for issuance records, change in sops need to
initiated change request and all issue copies are retrieve and new one implemented with
training.
MASTER FORMULA RECORDS
Master formula records are defined as written procedure that give the complete
description of all aspects of its manufacture, packing and control with an infection to ensure the
purity, identify, quality and strength of each dosage unit through its shelf life.
It includes the following information,
 Specifying a fixed formulation
 Identifying quality criteria for components
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
 Providing a set of manufacturing instruction in clear terms
 Describing systematic sampling procedures
 Listing precise assays, tests etc.
 Establishing methods for ensuring complete accountability for all materials Including
packing and labelling.
Types of Master Formula Records
 The master formula records give proportion of ingredients in the formulation.
 Master batch formula records, which specify absolute amounts of specific potent
ingredients and excipients.
MASTER PRODUCTION AND CONTROL RECORDS
Master production and control records are defined as detailed written instructions
including all operations starting from dispensing of raw materials till finishing of bulk products
and packaging operation of a particular product.
Master production and control record includes batch size, date of manufacture and full
signature (hand written) by one person and further independently checked, dated and signed by
second person.
SEQUENCE OF 9 SUBSECTION
2
MASTER
PRODUCTION
& CONTROL
RECORDS
NAME (TRADE OR
GENERIC),
STRENGTH,
COMPOSITION
PHYSICAL & AND CHEMICAL
DISCREPTION
METHOD OF
ADMINISTRATION
NAME OF ACTIVITES
& EXCEPIENTS,
TOTAL WEIGHT OF
DOSAGE UNIT
LIST OF
COMPONENTS BY
NAMES AND
CODES
WEIGHT/MEASURE
OF EACH
COMPONENTS
CALCULATED
EXCESS OF
COMPONENTS
THEORETICAL
WEIGHT
MAX%, MIN%
OF THEORETICAL
YIELD
DESCRIPTION OF
CONTAINERS,
CLOUSER, LABELS,
LABELING, PACKING
MATERIALS.
INSTRUCTIONS,
SAMPLING ,
TEST PROCEDURES,
SPECIFICATION,
SPECIAL NOTATIONS,
PRECAUTIONS.
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
BATCH PRODUCTION AND CONTROL RECORDS
Batch production and control records shall be prepared for each batch of drug product
produced and shall include complete information relating to the production and control of each
batch.
These records shall include:
 (a) An accurate reproduction of the appropriate master production or control record,
checked for accuracy, dated, and signed;
 (b) Documentation that each significant step in the manufacture, processing, packing, or
holding of the batch was accomplished.
 Dates;
 Identity of individual major equipment and lines used;
 Specific identification of each batch of component or in-process material used;
 Weights and measures of components used in the course of processing;
 In-process and laboratory control results;
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
 Inspection of the packaging and labeling area before and after use;
 A statement of the actual yield and a statement of the percentage of theoretical yield at
appropriate phases of processing;
 Complete labeling control records, including specimens or copies of all labeling used;
 Description of drug product containers and closures;
 Any sampling performed;
 Identification of the persons performing and directly supervising or checking each
significant step in the operation;
 Any investigation made according to.
 Results of examinations made in accordance with.
RAW MATERIALS
The schedule U to the drugs and cosmetic rules require following particulars to be shown in the
raw material records:-
 Date of receipt,
 Invoice number,
 Name and address of manufacturer/supplier,
 Batch number,
 Quantity received
 Pack size,
 Date of manufacture,
 Date of expiry
 Date of analysis and release/rejection by quality control,
 Analytical report number,
 Quantity issued,
 Date of issue,
 Name and batch number of the product for manufacture of which issued,
 Proper disposal of stocks
FORMAT
Name of the material:
RECEIPT
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
Labels and printed packaging material records
The Indian GMPs require the records of labels and printed packaging materials indicating
receipt, examination relating to testing and whether accepted or rejected to be maintained.
Labels
 What must be labelled?
-Containers, equipment, premises, products, intermediates, samples, standards etc.
-Status (quarantined, accepted, rejected, clean)
 Who has responsibility for labelling?
-QC and production for status labels
-Final product, intermediates, reagents etc.
Drug product container, closure, and labelling records.
These records shall include the following:
 The identity and quantity of each shipment of each lot of components, drug product
containers, closures, and labelling.
 The results of any test or examination performed.
 An individual inventory record of each component, drug product container, and closure
and, for each component, a reconciliation of the use of each lot of such component.
 Documentation of the examination and review of labels
 The disposition of rejected components, drug product containers, closure, and labelling.
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
QUALITY CONTROL RECORDS:
The quality control records must show:
 The date of performance of test;
 Identification of material;
 Name of supplier(in case of raw materials)
 Date of receipt
 Batch number
 Quantity received (in case of raw materials) (batch size in case of finished product)
 Date and quantity of sample taken
 Specifications employed for testing
 All data secured in the course of each test including all graphs, charts, printouts etc
 Calculations performed in connection with including units of measures, conversion
factors and equivalence factor
 A statement of the result of tests and how the results compare with established
standards of identity, purity and strength
 The initials or signature of person who performs the tests
 Certificate number issued
 Disposition of the quality control unit accepting or rejecting the material.
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
Standard operating procedure [Sop]
 Set of written instructions that is followed routinely or repetitively.
 Created culture where Quality objectives are Transparent, well understood, and
Undoubtedly these goals can be achieved by certain sets of Procedures called as
“Standard Operating Procedures”.
 Back bone of Pharmaceutical Industries.
 SOPs describe both technical and fundamental programmatic operational elements of
an organization that would be managed under a work plan or a Quality Assurance (QA)
Project Plan .
FDA’s three golden rules on proper documentation
1. If it isn’t written down, it didn’t happen.
2. If it isn’t written down properly, it didn’t happen either.
3. Don’t forget rules 1 and 2.
Objectives
 To describe the responsibilities of the coordinating center for managing and monitoring
the participating sites.
 To provide guidelines for accurate and timely data collection, resolution of data
clarifications (queries).
 To detail the regularly recurring work processes that are to be conducted or followed
within an organization.
 To facilitate consistent conformance to technical and quality system requirements and
to support data quality.
 To maintain their quality control and quality assurance processes
 To ensure compliance with governmental regulations.
 To serve as a training document for teaching users about the process for which the
SOP was written.
Why it is Essential ?
 An integral part of successful quality system.
 Plant’s effectiveness and efficacy.
 Regulatory requirement.
 To ensure that production operations are performed consistently to maintain quality
control of processes and products.
 To ensure that processes continue uninterrupted and are completed on a prescribed
schedule.
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
Benefits
 Provides information to perform job properly.
 To provide people with all safety, health, environmental and operational information
necessary to perform job properly.
 Also provides, consistency (very imp. In any of the field)
 Gives information in order to achieve pre-determined specification and quality end-
result.
 Minimizes variation and promotes quality. Steps can be reviewed in accident
investigations.
 Serves as a training document for users.
 SOPs assist to ensure that GMP is followed and achieved at all times.
 SOPs assist the pharmacy personnel to know who does what, and when, thus avoiding
confusion, and function overlapping. This also takes care of accountability and
responsibility.
 SOPs help to assure the quality and consistency of the service, and thus minimize harm
to the patient.
 SOPs are useful tools for training new members of staff.
 SOPs give clarity to the pharmacy personnel, to follow steps/procedures,
systematically, and uniformly.
SOP WRITING STYLE
 SOPs shall be written in a concise, step by step, easy to read and follow format.
 Information should not be complicated. The active voice and present verb tense should
be used.
 Should be simple and short.
 Routine procedures that are short and require few decisions can be written using simple
steps format.
 Long procedures consisting of more than 10 steps, with few decisions should be written
along with graphical format or hierarchical steps.
 Procedures that require many decisions should be written along with flow chart.
 Requirement for document identification and control, accountability and traceability
responsibility must be included with every SOP; this can be achieved by providing
consistent format.
Do While Writing SOP…
 Write in the presence tense. Don’t write in the past, conditional or future tense unless
you have good reason to do so.
 Avoid ambiguity.
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
 Be concise.
 Keep the words short and get to point.
 Move from one step to another step in logical manner.
 Highlight exception. Use a symbol to flag that this is an exception and how to handle it.
 Highlight warning. Again warn users that caution must be used in this scenario.
Warning must stand out; use a larger font or a warning icon.
 Reduce the word count where possible without altering the meaning of the text.
Do not do While Writing SOP…
 Introduce acronyms without explaining what it means.
 Don’t use the word “may”, “if possible” as it implies that the user can do something
under conditions. Instead be positive and tell them what to do.
INSIDE THE SOP
Company name and pagination.
The company name and pagination (e.g. page 4 of 7) must appear on every page.
Title
The title should be descriptive. The title should use directive language to declare what is being
done to what.
Identification
Procedures must be easily identified by giving unique number and version number. This
identification number of the SOP supports accountability of the document throughout the
facility and over time as it changes.
Review and approval
All SOPs shall have space for signature of initiator (the person who has written the
SOP) Reviewer (The persons who has reviewed the SOP) and approver (Quality Assurance
Head of the organization).
Purpose
The purpose or objective of the procedure should restate and expand well written title.
Expand or qualify the directive language used in the title (e.g. to describe the operation
procedure of compression machine)
Scope
The scope should provide limits to the use of procedure. The scope shall be written in
such a way that it answers following questions….
 Are there certain samples that are appropriate to test by this method?
 Do these operations apply only to certain equipment or certain departments?
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
 Is there a limit to the capacity, volume, or throughput of the procedure?
 State to what areas this procedure does apply and does not apply?
Responsibility
Who is responsible for performing the work described?
Who is responsible for implementing the procedure?
Procedure
Describe the procedure in a step by step, chronological manner. Use
active verbs and direct statements
SOP PROCESS
1. Sop Preparation
The organization should have a procedure in place for determining what procedures or
processes need to be documented.
• SOPs should be written by an individual who performs the tasks routinely or someone
who is directly responsible for the performance of the task.
2. SOP Review and Approval
 SOPs should be reviewed by one or more individuals with appropriate training and
experience with the process especially helpful if draft SOPs are actually tested by
individuals other than the original writer before the SOPs are finalized.
3. Frequency of Revisions and Reviews
 SOPs need to remain current to be useful. Therefore, whenever procedures are changed,
SOPs should be updated and re-approved. If desired, modify only the pertinent section
of an SOP and indicate the change date/revision number for that section in the Table of
Contents and the document control notation.
 SOPs should be also systematically reviewed on a periodic basis, e.g. every 1-2 years,
to ensure that the policies and procedures remain current and appropriate, or to
determine whether the SOPs are even needed.
4. Implementing SOP
 The most important step for implementing the SOP is in working area, train or retrain
the user. Everyone should follow the procedure exactly with each and every step in
detail, it is very important to train the user otherwise individual may interpret meaning
in different ways.
 While training the user trainer should share the reason WHY, SOP must performed
correctly. People are much more to follow when they understand importance of
procedure.
 Trainer should explain and demonstrate how each step in the SOP will be performed
and should assure them this will increase Quality of product by providing safety and
accuracy which will ultimately increase the confidence of the user.
5. Management of SOP
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
• Organization shall have SOP on Preparation, approval, revision and control of standard
Operating Procedure for better control and management of SOPs.
• Generally, administrative aspects of the SOP system such as distribution and filing are
well managed. On the other hand, overall system management, frequently characterized
by the lack of a system owner, is generally poor. If a system owner exists at all, his or
her responsibilities are limited.
Ideally a system owner
 Eliminates obsolete SOPs. (Which is not needed)
 Ensures that SOPs meet their quality requirements and are user friendly.
 Manages SOP change controls.
 Distributes SOPs.
 Ensures that SOPs are current.
 Ensures that new or changed SOPs are valid only after training has occurred and
provides training about the SOP system.
 Measures system performance and periodically reports results to management.
 Continuously improves the system.
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
Introduction of Semisolid & Liquid dosage forms
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
Pilfer Proof Cap Sealing Machine
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
 Label should include following details:
 Name of equipment :-
 Date 7 time of Cleaning :-
 Name of operator :-
 Name & batch no of previous product :-
 Name & batch no of next product :-
 Checked by :-
Title :- Cleaning of manufacturing
Vessel.
Ref. No :-
Version :-
Name of Mfg. :-
Department :-
Effective Date :-
I D No :-
Page No :-
Review Date :-
Prepared By Approved By Authorized By
SOP for Mixing of Aqueous & Oily phase
Record the details of processing.
Transfer the finished product to filling unit.
Allow the product to cool at specified temperature and homogenize it.
Stop agitation and heating after the specific time gap.
Locate mixing process intermittently through sight glass.
Start heating and agitation at predetermined rate for specified time period.
Open the inlet valve & Transfer the aq. And oil phase from their
respective mixing tanks.
Check the closure of all the outlet valves and “cleaned” label.
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
BATCH MANUFACTURING RECORDS
Introduction
 Batch manufacturing records should be prepared for each intermediate and
API/formulation and should include complete information relating to the manufacturing
and control of each batch.
 The batch manufacturing record should be checked before issuance to assure that it is
the correct version and a legible accurate reproduction of the appropriate master
production instruction.
 Before any processing begins, a check should be performed and recorded to ensure that
the equipment and workstation are clear of previous products, documents, or materials
not required for the planned process and that the equipment is clean and suitable for
use.
 These records should be numbered with a unique batch or identification number and
dated and signed when issued.
DEFINITION
The “Batch Manufacturing Record” is the necessary quality and GMP documentation for
tracing the complete cycle of manufacturing batch or lot
Documentation ….
Documentation includes ………
1) Raw material records. Receipt, Issue or disposal
2) Labels & Printed packaging material records.
3) Master formula records
4) Batch production records ( BMR & IP control record.)
5) Standard operating procedures. (SOP)
Batch manufacturing record:
BMR is a documentation that provides the history of a batch from the raw material stage to completion
of the batch or lot.
Product name :-_____
Generic Name :-_____ Batch no.:-_____
MFR Ref. No. :-______ Batch Size:-_____
Date of Starting:-____ Date of Completion:-___
Dr Gajanan S Sanap M. Pharm., PhD
31st
July 2017 Documentation
Master Formula:
Raw material requirement calculation :-
Actual potency of raw material may vary each time. So calculation of required
quantity is done according to raw material analytical report
BATCH PACKAGING RECORD :-
• Product name:_______________
• Batch No: ________________
• Packaging Description:__________
• Precoding of labels and printed packaging materials examined and verified
by:- (attach specimen)
• Quantity of packing material received( PM store:___________________
• Quantity of packing material approved(By PM department):_____________
• Total quantity packed:________________
• Date of completion:__________________
• Qty collected as samples by Q.C department:____________
Date Start
time
Close
time
Name of person responsible for
packaging Other
operations
packaging Checking
Packed
containers
Counting &
filling in boxes
 CLEANING TICKET:
 Name of the equipment_____________
 last product handled _______________
 Lot No_______
 Cleaned & Ready for product _________
 Lot No_______
 Cleaned By _____________________
 Date____________
 Supervisors signature_______________ .

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Documentation

  • 1. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation DOCUMENTATION Introduction Document is a written report or record that provides information especially of an official or legal nature. Documentation is a method of preparing a written material, which describe the process in terms of specification, instructions etc. The drugs and cosmetic rules under the “conditions of licenses” and under schedule M require a manufacturer of drugs to maintain various records. The GDP can be defined as “Good documentation practice is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. Clearly written documents prevent errors of various activities in pharma each and every activity is written in specific documents such as SOPs and strictly followed. Spoken communications may be create errors so that all important documents such as Master formula record , procedure and record must be free from errors and Documented. It is difficult to make a list of required documents and totally depend upon Companies activity or environment. Followings are the activity factors considered during designing of any documents. 1. Type of formulation 2. Country requirements 3. Availability of ERP or SAP system Purpose of Documentations • Defines specifications and procedures for all materials and methods of manufacture and control • Ensures all personnel know what to do and when to do it • Ensure that authorized persons have all information necessary for release of product • Ensures documented evidence, traceability, provide records and audit trail for investigation • Ensures availability of data for validation, review and statistical analysis. Importance of Documentation  It provides necessary working details.  Reduces the risk of mistake.  Help in tracing the deviation from the expected yield.  They help in decreasing the batch to batch variation so that quality of product is kept within the limits of acceptability.  Considered as the history of batch operations.  Self-inspection of procedure. ***Documentation and records are essential for obtaining accreditation, certification of ISOs and approvals by Federal Bodies.
  • 2. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation Classification of Documentation Following are the classification of Documents • For organization & Personnel. • For Buildings & facilities • For Equipments. • For Handling of R.M.& P.M. • For Production & process control. • For Packaging & Labeling control. • For Holding & Distribution • For Laboratory Control. • For Records & Reports. • For Return & Salvaged finished products. Type of documents used in pharmaceuticals 1. Specifications: as per MHRA Specifications describe in detail the requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation. We need specification for: 1. Active and inactive materials 2. Primary printed and packing materials 3. Intermediate and semi finished product 4. Finished product 2. SOPs: it is a written, authorized functional instruction used as a reference by the person responsible for performance and are also used for training new operators in the performance of the procedure. 3. Test method: it is a written and approved documents describe the detailed testing procedure. 4 List: Documents contain a catalog of any object such as list of equipments. 5. Certificates of Analysis: it is an authentic documents shows the analytical reports and decision of acceptance/rejections • Label • Records • Organ gram • Job description Batch Manufacturing records: It is an important document issued for every batch of product to assure, review and record keeping of any product batch. There are following major content of BMR.
  • 3. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation 1. Name of product, generic name, strength, shelf life, manufacturing date and exp date. 2. A complete list of ingredients with full description, codes and quantity to be issued. 3. A statement for theoretical yield and reconciliation. 4. A complete MFG and control instructions, sampling and testing procedure, specification and precaution to be followed. 5. A statement for processing location and equipment. 6. The method or reference to method to be used for preparing the critical equipment including cleaning, assembling, calibrating and sterilizing. 7. Dates and time of all activities 8. Line clearance procedure in every steps 9. Labeling control and specimen for coding in primary, secondary and tertiary packing materials 10. Deviation record 11. Result of examine made. Preparation, issues and uses of Documents Documents should be carefully and logically specify to prevent wrong uses. All necessary information’s are written unambiguously. Each document includes: 1. Company name 2. Purpose and title of documents
  • 4. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation 3. Identification No and revision No. 4. Date of authorization 5. Date of review 6. Signature of prepared by, checked and authorized by. 7. Distribution list 8. Page no. 9. Reason for revision should be documented. 10. Abbreviation and reference Each document is clear and computerized so that it is readable, issued documents signed by a concern person to indicate a verified issue. Any correction is made by cutting with single line with signature and date, do not overwrite. Document to filled have a sufficient space, ball ink pen should be used for hand written filling. Document control The process by which a manufacturer ensures that all procedures used and documents generated in G.M.P. – related actions are current, accurate and approved. Purpose of document control to control issuance, possession, use and revision of master documents including Standard Operating Procedures Data collection forms Validation Protocols Master formulae Batch records Function of Quality Assurance Unit Initially document is prepared by concern department as draft and draft is reviewed by dept. head and final draft is send to QA department that convert a draft to a final documents checked and approved by authorize person. Control copies are issued to concern department and issuance records are maintained. After approval of documents such as sops quality assurance must ensure that all users/concerned department gets training before the implementation of the sops record of such training must be maintained. A training co-coordinator preferably the head of user department or any designated individuals shall be responsible for organizing the training. After successful implementation of training on any sops, the sops become effective. Original sops are stamped as “MASTER COPY” with red ink, master copy are stored under supervision and photocopy of master copy duly stamped as “CONTROL COPY” in blue color. Sops distribution list should be maintained for issuance records, change in sops need to initiated change request and all issue copies are retrieve and new one implemented with training. MASTER FORMULA RECORDS Master formula records are defined as written procedure that give the complete description of all aspects of its manufacture, packing and control with an infection to ensure the purity, identify, quality and strength of each dosage unit through its shelf life. It includes the following information,  Specifying a fixed formulation  Identifying quality criteria for components
  • 5. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation  Providing a set of manufacturing instruction in clear terms  Describing systematic sampling procedures  Listing precise assays, tests etc.  Establishing methods for ensuring complete accountability for all materials Including packing and labelling. Types of Master Formula Records  The master formula records give proportion of ingredients in the formulation.  Master batch formula records, which specify absolute amounts of specific potent ingredients and excipients. MASTER PRODUCTION AND CONTROL RECORDS Master production and control records are defined as detailed written instructions including all operations starting from dispensing of raw materials till finishing of bulk products and packaging operation of a particular product. Master production and control record includes batch size, date of manufacture and full signature (hand written) by one person and further independently checked, dated and signed by second person. SEQUENCE OF 9 SUBSECTION 2 MASTER PRODUCTION & CONTROL RECORDS NAME (TRADE OR GENERIC), STRENGTH, COMPOSITION PHYSICAL & AND CHEMICAL DISCREPTION METHOD OF ADMINISTRATION NAME OF ACTIVITES & EXCEPIENTS, TOTAL WEIGHT OF DOSAGE UNIT LIST OF COMPONENTS BY NAMES AND CODES WEIGHT/MEASURE OF EACH COMPONENTS CALCULATED EXCESS OF COMPONENTS THEORETICAL WEIGHT MAX%, MIN% OF THEORETICAL YIELD DESCRIPTION OF CONTAINERS, CLOUSER, LABELS, LABELING, PACKING MATERIALS. INSTRUCTIONS, SAMPLING , TEST PROCEDURES, SPECIFICATION, SPECIAL NOTATIONS, PRECAUTIONS.
  • 6. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation BATCH PRODUCTION AND CONTROL RECORDS Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch. These records shall include:  (a) An accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed;  (b) Documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished.  Dates;  Identity of individual major equipment and lines used;  Specific identification of each batch of component or in-process material used;  Weights and measures of components used in the course of processing;  In-process and laboratory control results;
  • 7. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation  Inspection of the packaging and labeling area before and after use;  A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing;  Complete labeling control records, including specimens or copies of all labeling used;  Description of drug product containers and closures;  Any sampling performed;  Identification of the persons performing and directly supervising or checking each significant step in the operation;  Any investigation made according to.  Results of examinations made in accordance with. RAW MATERIALS The schedule U to the drugs and cosmetic rules require following particulars to be shown in the raw material records:-  Date of receipt,  Invoice number,  Name and address of manufacturer/supplier,  Batch number,  Quantity received  Pack size,  Date of manufacture,  Date of expiry  Date of analysis and release/rejection by quality control,  Analytical report number,  Quantity issued,  Date of issue,  Name and batch number of the product for manufacture of which issued,  Proper disposal of stocks FORMAT Name of the material: RECEIPT
  • 8. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation Labels and printed packaging material records The Indian GMPs require the records of labels and printed packaging materials indicating receipt, examination relating to testing and whether accepted or rejected to be maintained. Labels  What must be labelled? -Containers, equipment, premises, products, intermediates, samples, standards etc. -Status (quarantined, accepted, rejected, clean)  Who has responsibility for labelling? -QC and production for status labels -Final product, intermediates, reagents etc. Drug product container, closure, and labelling records. These records shall include the following:  The identity and quantity of each shipment of each lot of components, drug product containers, closures, and labelling.  The results of any test or examination performed.  An individual inventory record of each component, drug product container, and closure and, for each component, a reconciliation of the use of each lot of such component.  Documentation of the examination and review of labels  The disposition of rejected components, drug product containers, closure, and labelling.
  • 9. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation QUALITY CONTROL RECORDS: The quality control records must show:  The date of performance of test;  Identification of material;  Name of supplier(in case of raw materials)  Date of receipt  Batch number  Quantity received (in case of raw materials) (batch size in case of finished product)  Date and quantity of sample taken  Specifications employed for testing  All data secured in the course of each test including all graphs, charts, printouts etc  Calculations performed in connection with including units of measures, conversion factors and equivalence factor  A statement of the result of tests and how the results compare with established standards of identity, purity and strength  The initials or signature of person who performs the tests  Certificate number issued  Disposition of the quality control unit accepting or rejecting the material.
  • 10. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation Standard operating procedure [Sop]  Set of written instructions that is followed routinely or repetitively.  Created culture where Quality objectives are Transparent, well understood, and Undoubtedly these goals can be achieved by certain sets of Procedures called as “Standard Operating Procedures”.  Back bone of Pharmaceutical Industries.  SOPs describe both technical and fundamental programmatic operational elements of an organization that would be managed under a work plan or a Quality Assurance (QA) Project Plan . FDA’s three golden rules on proper documentation 1. If it isn’t written down, it didn’t happen. 2. If it isn’t written down properly, it didn’t happen either. 3. Don’t forget rules 1 and 2. Objectives  To describe the responsibilities of the coordinating center for managing and monitoring the participating sites.  To provide guidelines for accurate and timely data collection, resolution of data clarifications (queries).  To detail the regularly recurring work processes that are to be conducted or followed within an organization.  To facilitate consistent conformance to technical and quality system requirements and to support data quality.  To maintain their quality control and quality assurance processes  To ensure compliance with governmental regulations.  To serve as a training document for teaching users about the process for which the SOP was written. Why it is Essential ?  An integral part of successful quality system.  Plant’s effectiveness and efficacy.  Regulatory requirement.  To ensure that production operations are performed consistently to maintain quality control of processes and products.  To ensure that processes continue uninterrupted and are completed on a prescribed schedule.
  • 11. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation Benefits  Provides information to perform job properly.  To provide people with all safety, health, environmental and operational information necessary to perform job properly.  Also provides, consistency (very imp. In any of the field)  Gives information in order to achieve pre-determined specification and quality end- result.  Minimizes variation and promotes quality. Steps can be reviewed in accident investigations.  Serves as a training document for users.  SOPs assist to ensure that GMP is followed and achieved at all times.  SOPs assist the pharmacy personnel to know who does what, and when, thus avoiding confusion, and function overlapping. This also takes care of accountability and responsibility.  SOPs help to assure the quality and consistency of the service, and thus minimize harm to the patient.  SOPs are useful tools for training new members of staff.  SOPs give clarity to the pharmacy personnel, to follow steps/procedures, systematically, and uniformly. SOP WRITING STYLE  SOPs shall be written in a concise, step by step, easy to read and follow format.  Information should not be complicated. The active voice and present verb tense should be used.  Should be simple and short.  Routine procedures that are short and require few decisions can be written using simple steps format.  Long procedures consisting of more than 10 steps, with few decisions should be written along with graphical format or hierarchical steps.  Procedures that require many decisions should be written along with flow chart.  Requirement for document identification and control, accountability and traceability responsibility must be included with every SOP; this can be achieved by providing consistent format. Do While Writing SOP…  Write in the presence tense. Don’t write in the past, conditional or future tense unless you have good reason to do so.  Avoid ambiguity.
  • 12. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation  Be concise.  Keep the words short and get to point.  Move from one step to another step in logical manner.  Highlight exception. Use a symbol to flag that this is an exception and how to handle it.  Highlight warning. Again warn users that caution must be used in this scenario. Warning must stand out; use a larger font or a warning icon.  Reduce the word count where possible without altering the meaning of the text. Do not do While Writing SOP…  Introduce acronyms without explaining what it means.  Don’t use the word “may”, “if possible” as it implies that the user can do something under conditions. Instead be positive and tell them what to do. INSIDE THE SOP Company name and pagination. The company name and pagination (e.g. page 4 of 7) must appear on every page. Title The title should be descriptive. The title should use directive language to declare what is being done to what. Identification Procedures must be easily identified by giving unique number and version number. This identification number of the SOP supports accountability of the document throughout the facility and over time as it changes. Review and approval All SOPs shall have space for signature of initiator (the person who has written the SOP) Reviewer (The persons who has reviewed the SOP) and approver (Quality Assurance Head of the organization). Purpose The purpose or objective of the procedure should restate and expand well written title. Expand or qualify the directive language used in the title (e.g. to describe the operation procedure of compression machine) Scope The scope should provide limits to the use of procedure. The scope shall be written in such a way that it answers following questions….  Are there certain samples that are appropriate to test by this method?  Do these operations apply only to certain equipment or certain departments?
  • 13. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation  Is there a limit to the capacity, volume, or throughput of the procedure?  State to what areas this procedure does apply and does not apply? Responsibility Who is responsible for performing the work described? Who is responsible for implementing the procedure? Procedure Describe the procedure in a step by step, chronological manner. Use active verbs and direct statements SOP PROCESS 1. Sop Preparation The organization should have a procedure in place for determining what procedures or processes need to be documented. • SOPs should be written by an individual who performs the tasks routinely or someone who is directly responsible for the performance of the task. 2. SOP Review and Approval  SOPs should be reviewed by one or more individuals with appropriate training and experience with the process especially helpful if draft SOPs are actually tested by individuals other than the original writer before the SOPs are finalized. 3. Frequency of Revisions and Reviews  SOPs need to remain current to be useful. Therefore, whenever procedures are changed, SOPs should be updated and re-approved. If desired, modify only the pertinent section of an SOP and indicate the change date/revision number for that section in the Table of Contents and the document control notation.  SOPs should be also systematically reviewed on a periodic basis, e.g. every 1-2 years, to ensure that the policies and procedures remain current and appropriate, or to determine whether the SOPs are even needed. 4. Implementing SOP  The most important step for implementing the SOP is in working area, train or retrain the user. Everyone should follow the procedure exactly with each and every step in detail, it is very important to train the user otherwise individual may interpret meaning in different ways.  While training the user trainer should share the reason WHY, SOP must performed correctly. People are much more to follow when they understand importance of procedure.  Trainer should explain and demonstrate how each step in the SOP will be performed and should assure them this will increase Quality of product by providing safety and accuracy which will ultimately increase the confidence of the user. 5. Management of SOP
  • 14. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation • Organization shall have SOP on Preparation, approval, revision and control of standard Operating Procedure for better control and management of SOPs. • Generally, administrative aspects of the SOP system such as distribution and filing are well managed. On the other hand, overall system management, frequently characterized by the lack of a system owner, is generally poor. If a system owner exists at all, his or her responsibilities are limited. Ideally a system owner  Eliminates obsolete SOPs. (Which is not needed)  Ensures that SOPs meet their quality requirements and are user friendly.  Manages SOP change controls.  Distributes SOPs.  Ensures that SOPs are current.  Ensures that new or changed SOPs are valid only after training has occurred and provides training about the SOP system.  Measures system performance and periodically reports results to management.  Continuously improves the system.
  • 15. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation Introduction of Semisolid & Liquid dosage forms
  • 16. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation Pilfer Proof Cap Sealing Machine
  • 17. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation  Label should include following details:  Name of equipment :-  Date 7 time of Cleaning :-  Name of operator :-  Name & batch no of previous product :-  Name & batch no of next product :-  Checked by :- Title :- Cleaning of manufacturing Vessel. Ref. No :- Version :- Name of Mfg. :- Department :- Effective Date :- I D No :- Page No :- Review Date :- Prepared By Approved By Authorized By SOP for Mixing of Aqueous & Oily phase Record the details of processing. Transfer the finished product to filling unit. Allow the product to cool at specified temperature and homogenize it. Stop agitation and heating after the specific time gap. Locate mixing process intermittently through sight glass. Start heating and agitation at predetermined rate for specified time period. Open the inlet valve & Transfer the aq. And oil phase from their respective mixing tanks. Check the closure of all the outlet valves and “cleaned” label.
  • 18. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation BATCH MANUFACTURING RECORDS Introduction  Batch manufacturing records should be prepared for each intermediate and API/formulation and should include complete information relating to the manufacturing and control of each batch.  The batch manufacturing record should be checked before issuance to assure that it is the correct version and a legible accurate reproduction of the appropriate master production instruction.  Before any processing begins, a check should be performed and recorded to ensure that the equipment and workstation are clear of previous products, documents, or materials not required for the planned process and that the equipment is clean and suitable for use.  These records should be numbered with a unique batch or identification number and dated and signed when issued. DEFINITION The “Batch Manufacturing Record” is the necessary quality and GMP documentation for tracing the complete cycle of manufacturing batch or lot Documentation …. Documentation includes ……… 1) Raw material records. Receipt, Issue or disposal 2) Labels & Printed packaging material records. 3) Master formula records 4) Batch production records ( BMR & IP control record.) 5) Standard operating procedures. (SOP) Batch manufacturing record: BMR is a documentation that provides the history of a batch from the raw material stage to completion of the batch or lot. Product name :-_____ Generic Name :-_____ Batch no.:-_____ MFR Ref. No. :-______ Batch Size:-_____ Date of Starting:-____ Date of Completion:-___
  • 19. Dr Gajanan S Sanap M. Pharm., PhD 31st July 2017 Documentation Master Formula: Raw material requirement calculation :- Actual potency of raw material may vary each time. So calculation of required quantity is done according to raw material analytical report BATCH PACKAGING RECORD :- • Product name:_______________ • Batch No: ________________ • Packaging Description:__________ • Precoding of labels and printed packaging materials examined and verified by:- (attach specimen) • Quantity of packing material received( PM store:___________________ • Quantity of packing material approved(By PM department):_____________ • Total quantity packed:________________ • Date of completion:__________________ • Qty collected as samples by Q.C department:____________ Date Start time Close time Name of person responsible for packaging Other operations packaging Checking Packed containers Counting & filling in boxes  CLEANING TICKET:  Name of the equipment_____________  last product handled _______________  Lot No_______  Cleaned & Ready for product _________  Lot No_______  Cleaned By _____________________  Date____________  Supervisors signature_______________ .