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Standard operating procedure in pharmaceutical industries,SOP,MFR,Master Formula Record, how to write SOP, Sop Content, MFR Content
1. Standard Operating
Procedure in
Pharmaceutical
Industries
Prepared by: Simran Kukreja
Guided by: Dr. Ajazuddin (Professor)
Product Development Laboratory
Rungta College of Pharmaceutical Sciences
and Research, Bhilai, C.G., 490023
Email: simrankukreja.pharmacy@gmail.com
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2. CONTENT
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1. Standard Operating Procedure
- Introduction
- Objectives
- Benefits
- Types of SOP
- SOP Writing Style
- DOâs
- Donâts
- SOP Content
- SOP Process
- SOP for Tablet Compression
2. Master Formula Record
- Content
3. INTRODUCTION
⢠Standard Operating Procedure is a set of step by step
written instructions intended to document how to
perform a routine activity.
⢠Back bone of pharmaceutical industry.
⢠Integral part of Quality assurance(QA).
⢠Provides details of appropriate quality, cost and time
constraints.
SOP - AIM FOR QUALITY
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4. OBJECTIVES
⢠To maintain the quality control and quality assurance.
⢠To serve as a training document for teaching users
about the process for which the SOP was written.
⢠To facilitate consistent conformance to quality system
requirements and to support data quality.
⢠To provide guidelines for accurate and timely data
collection.
⢠Uniformity of performance.
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5. ContdâŚ
⢠Efficiency and quality output.
⢠Reduce miscommunication and failure to comply
with industry regulations.
⢠To carry out operations correctly and always in
same manner.
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6. BENEFITS
⢠Provides information to perform job properly.
⢠To provide people with all safety, health, environmental
and operational information necessary to perform the
job properly.
⢠Serves as a training document for users.
⢠Minimizes variation and promotes quality. Steps can be
reviewed in accident variations.
⢠Also provide, consistency(very important).
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7. Contd..
⢠Useful tool for training new members of staff.
⢠SOP assist to ensure that GMP is followed and
achieved at all times.
⢠SOPâs help to assure the quality and consistency of the
services, and thus minimize harm to the patient.
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8. TYPES OF SOP
⢠Analytical method
⢠Preparation of Reagent
⢠Quality Assurance
⢠For operating instruments, equipment and
apparatus
⢠Safety & Precautions
⢠Methodic
⢠Receiving and registration of sample
⢠Fundamental SOP
⢠To deal with complaints
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9. SOP WRITING STYLE
.
⢠SOPâs shall be written in a concise, step by step, easy to read
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, should be
written along with graphical format or hierarchical steps.
⢠Procedures that require many decisions should be written along
with flowchart.
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10. DOâs
⢠Write in present tense. Donât use past tense, condition of
future tense unless you have good reason to do so.
⢠Avoid ambiguity and be concise.
⢠Reduce the word count where possible without changing
the meaning of the text.
⢠Keep the words short and get to point.
⢠Highlight exceptions. Use a symbol to flag that this is an
exception and how to handle it.
â˘Highlight warnings and use a larger or a warning icon.
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11. DONâTs
⢠Introduce acronyms without explaining what it means.
⢠Donât use the word â may â, â if possibleâ as it implies
that the user can do something under conditions. Instead
be positive and tell them what to do.
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12. CONTENT OF SOP
⢠Company name and pagination
⢠Title
⢠Identification
⢠Review and approval
⢠Purpose
⢠Scope
⢠Responsibility
⢠Procedure
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13. SOP PROCESS
⢠SOP Preparation
⢠SOP Review and Approval
⢠Frequency of revisions and reviews
⢠Implementing SOP
⢠Management of SOP
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15. SOP - TABLET COMPRESSION
⢠Clean the compression machine as per respective SOP.
⢠Make sure that the compression area has been clean
properly.
⢠Clean the dust extractors, its pipes, racks, door frames
and return filters of Air Handling Unit.
⢠Check it visually for intactness and absence of leakage.
⢠Intimate quality control department to collect swab
samples as per requirements.
⢠After receiving the approval from QC department put
ââcleaned labelâ to all equipments.
â˘
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16. ContdâŚ
⢠Clean with 70% isopropyl alcohol before taking
clearance from QC department.
⢠As compression of product is to be started, remove the
âcleaned statusâ and affix label to the machine along with
product name & Batch details.
⢠Issue the punch set suitable for the compression as per
SOP.
⢠Set the compression machine as per SOP and check the
setting of machine.
⢠Set the machine as per tablet parameters given in BMR.
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17. Contd..
⢠Destroy the tablets of first few rotations before starting
the machine for the compression of batch as per SOP.
⢠Collect the tablets generated during machine setting in a
container. Keep it label & pack.
⢠Stop the compression as the material in the hopper
reaches the lowest level.
⢠Clean all the containers from outside & transfer it to
store with label having all batch details.
⢠Remove the punch sets and clean it as per the SOP.
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18. MASTER FORMULA RECORD
⢠A Document or set of documents specifying the starting
materials with their quantities and the packaging
materials, together with a description of the procedure and
the precautions required to produce a specified quantity of
a finished product as well as processing instructions,
including in process controls.
⢠MFR can also be said and written as â Master Formulaeâ,
âManufacturing Recordâ, âMaster Production and Control
Recordâ.
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19. It includes
⢠Batch Manufacturing Records(BMR)
⢠Batch packing record(BPR).
⢠Intermediate/ packing material/ finished product
specifications.
⢠Specimen of printed packaging material.
⢠All documents of â Master Formula Recordâ should be
stamped as â Master Copyâ in green at the non text
side(back side).
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20. CONTENT OF MFR
⢠the name of the product together with product reference
code relating to its specifications.
⢠the patent or proprietary name of the product along with
the generic name, description of the dosage form strength,
composition of the product and batch size.
⢠a statement of processing location and the principle
equipments to be used.
⢠the name, quantity, and the reference number of starting
material to be used.
⢠a statement of expected yield with acceptable limits and
relevant intermediate yield, where applicable.
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21. Contd..
⢠the methods, or reference to the method, to be used for
preparing the critical equipments including cleaning,
assembling, calibrating, sterilizing.
⢠detailed step wise processing instructions and the time
for each step.
⢠the instructions for in process control with their limits.
⢠the requirements for storage conditions of the products,
including the container, labeling and special storage
conditions where applicable.
⢠any special precaution to be observed and packing
details and specimens label.
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