Prepared BY- Ruhid Hasan from:- University of Development Alternative dept. of Pharmacy [Life Scince]

1. GOOD MANUFACTURING
PRACTICES
&
STANDARD OPERATING
PROCEDURE
Assurance of Quality Pharmaceuticals Products
University of Development Alternative

2. OUTLINE
› What is Good manufacturing practice?
› THE BENEFITS OF GMPs
› MAIN PRINCIPLES OF GMP
› What is an S.O.P?
› BENEFITS OF SOP
› Features of A “GOOD” Standard Operating Procedure
› TYPICAL STRUCTURE FOR SOPS

3. What is “GOOD MANUFACTURING PRACTICE”?
Good Manufacturing Practices (GMP) are the part of quality
assurance that ensures that drugs are consistently produced
and controlled in such a way to meet the quality standards
appropriate to their intended use, as required by the marketing
authorization.
Based on fundamental concepts of Quality Assurance Principles
Control Quality, safety, and effectiveness must be designed
and built into the product Quality cannot be inspected or tested
into a finished product Each step of manufacturing must be
controlled to maximize the chances that the Finished Good will
be acceptable

4. WHAT ARE THE BENEFITS OF GMPs?
› – They outline a Quality System that reduces or prevents
errors
› – Ensures products are safe for use in humans
› – Prevent/control contamination and cross-contamination
› – Minimizes variations in potency of the drug
› – Ensures reproducible physiological activity
› – Prevent side effects and toxicity due to variations in drug
content and potency
› – Prevents mislabeling and adulteration

5. MAIN KEY PRINCIPLES OF GMP
› Organization and Personnel
› Buildings and Facilities
› Equipment
› Control of Components and Drug Product Containers and Closures
› Production and Process Controls
› Packaging & Labeling Control
› Holding & Distribution
› Laboratory Controls
› Records & Reports
› Returned & Salvaged Drug Product

6. MAIN KEY PRINCIPLES OF GMP
› Organization and Personnel
– Management Responsibility Responsible for facility, quality system,
organizational structure, ensuring adequate resources
– Responsible for actions of those reporting to them
– Responsible for reviewing products annually, and procedures
routinely
– Responsible for providing adequate resources to perform operations
Facilities, personnel, training, equipment, etc.

7. MAIN KEY PRINCIPLES OF GMP
› Buildings and Facilities
– Buildings must be designed with adequate size and space for operations
– Facilities must be validated There must be a good flow pattern for
personnel, materials, products and waste materials. The facility must be
easy to clean and sanitize
– Environmental controls must be in place
– Utilities must be validated (water systems, electrical, etc)
› Equipment
Equipment should be selected based on the intended use and clean
ability if it is to be in a clean room Equipment must be placed in an
appropriate location. Equipment must be properly qualified.

8. MAIN KEY PRINCIPLES OF GMP
› Component/Materials Control
Suppliers must be evaluated and approved and monitored for quality
Incoming Materials must be tested before they can be accepted for use
Materials must be placed in stores or issued according to FIFO (stock
rotation) Materials must be stored so that they are not mixed up,
damaged, or contaminated.
› Production/Process Control Have & Follow Procedures: A good
procedure is a written step-by-step procedure that provides a roadmap
for Controlled and Consistent performance. Examples:
› – (Manufacturing) Work Instructions
› – Operating Procedures
› – Testing Procedures
› – Quality Manual Deviations must be recorded and justified

9. MAIN KEY PRINCIPLES OF GMP
› Packaging and Labeling Control Label is a display of a written, printed or
graphic matter upon the immediate container of any article Labeling is
the label and any other packaging material or container that is printed
(ex. IFU, advertising materials) Procedures must exist that document
receiving, identity, storage, handling, sampling, and testing of labels and
ensure that integrity is maintained throughout production and use of
product
› Holding and Distribution Warehousing procedures should address…
…Quarantine of drug products …storage of products under appropriate
conditions Distribution procedures should address… …FEFO (First
Expiring First Out) …traceability of product lots/batches
› Laboratory Controls Written procedures must be established & followed
All actions must be documented at the time of performance

10. MAIN KEY PRINCIPLES OF GMP
› Records and Reports Quality Records are the proof that the
procedures were followed and they show traceability of
product.
› Quality Records
– Records are legal documents and can be subpoenaed in a court of law
as evidence
– Signatures on documentation have the same meaning as on any kind
of contract
– Information must be recorded and signed for at the time of
performance on the original record

11. What is an S.O.P?

12. What is “Standard Operating Procedure (SOP)”
› A Standard Operating Procedure (SOP) is a set of written
instructions that document a routine or repetitive activity
followed by an organization.

13. Features of A “GOOD” Standard Operating
Procedure
› Should provide all the information necessary to perform a task
› Is usually specific to the equipment used for the procedure
› Should be detailed
› Should “Stand Alone”
› Should provide Quality Control information
› Should provide References

14. BENEFITS OF SOP
› 1. To perform a job properly.
› 2. To ensure that production operations are performed
consistently.
› 3. To ensure that processes continue uninterrupted and are
completed on a prescribed schedule.
› 4. To ensure that no failures occur in manufacturing and other
processes for which the SOP was written.
› 5. To ensure that approved procedures are followed in
compliance with company and government regulations.
Quality Assurance, Quality Square Industry.

15. BENEFITS OF SOP
› 6. To serve as a training document for teaching users about
the process.
› 7. To serve as a checklist for co-workers who observe job
performance to reinforce proper performance.
› 8. To serve as a checklist for auditors.
› 9. To serve as an historical record for the Change over.
› 10.To serve as an explanation in review of accident
investigations

16. TYPICAL STRUCTURE FOR SOPS
1. Title Page:
This includes
1) the title of the procedure,
2) an SOP identification number,
3) date of issue or revision,
4) the name of the agency/division/branch the SOP applies to,
and
5) the signatures of those who prepared and approved of the
SOP. This can be formatted however you like, as long as the
information is clear.

17. › Table of Contents:
This is only necessary if SOP is quite long, allowing for ease of
reference. A simple standard outline is what you'd find here.
› Quality Assurance/Quality Control:
A procedure is not a good procedure if it cannot be checked.
Have the necessary materials and details provided so the reader
can make sure they've obtained the desired results. This may or
may not include other documents, like performance evaluation
samples.

18. › Reference:
Be sure to list all cited or significant references. If reference
other SOPs, its important to attach the necessary information in
the appendix.

19. Questions or Any Query ?

20. CONTACT
Name: Ruhid Hasan
ID: 031161009
Batch: 48th
Pharmacy Dept.