Principles of good manufacturing practice

1. Principles of Good Manufacturing
Practice
1. Quality management.
2. Personnel.
3. Premises and equipment
4. Documentation
5. Production areas
6. Quality control
7. Contract manufacturing
8. Complaints and product recall
9. Self - inspection

2. Quality management
1. Quality assurance
2. Good manufacturing practice
3. Quality control
4. Quality review.

3. Good Manufacturing Practice
 GMP is part of QA which ensures that products are consistently
produced and controlled to the quality standards appropriate to
their intended use and as required by the marketing authorization
or product specifications.
 GMP is mainly concerned with production and quality control.
 Basic requirements of GMP

4. a. Manufacturing processes are clearly defined.
b. Validated process and changes.
c. All GMP facilities are provided.
d. Qualified trained personnel.
e. Adequate premises and areas..
f. Suitable equipment and services.
g. Correct materials, containers and labels.
h. Approved written and clear procedures and instructions.
i. Suitable storage and transport.
j. Records are made and retained.
k. Recall and complaints system is available together with investigational
measures.

5. Quality Control
 QC is a part of GMP, concerned with sampling, specifications and
testing, and with the organization, documentation and release
procedures
 Basic requirements of QC

6. a. Adequate facility, trained personnel and approved procedures.
b. Sampling are taken by trained and approved method.
c. Methods are validated.
d. Records are made.
e. Finished products are released complying the marketing authorization.
f. Records for inspection, testing, product assessment including production
documentation.
g. Issuing release certification.
h. Retain sufficient samples of starting material and finished product.

7. Quality Review
 quality review should be conducted annually and documented.
 quality review should include:

8. a. Starting materials and packaging materials.
b. Critical in-process control and finished product results.
c. Batches that failed specifications and investigations.
d. Review of significant deviations and in-conformance and corrective actions.
e. Changes validation.
f. Marketing authorization submitted or refused dossiers.
g. Results of stability monitoring program.
h. Returns, complaints and recall.
i. Adequacy of process or equipment corrective action.
j. Review of post-marketing commitments.
k. Qualification of equipment and utilities.
l. Up-to-date technical agreements.

9. Principles of Good Manufacturing
Practice
1. Quality management.
2. Personnel.
3. Premises and equipment
4. Documentation
5. Production areas
6. Quality control
7. Contract manufacturing
8. Complaints and product recall
9. Self - inspection

10. Personnel
• Sufficient qualified personnel to carry out GMP tasks.
• Responsibilities should be clearly defined.
• Training should be continuously conducted.
• Hygiene.
- Detailed hygiene program
- Medical examination.
- Ensure that no infected person is engaged in the
manufacturing.
- Protective garments.
- Eating , drinking, smoking, chewing or storage of food,
personnel medications are forbidden.
- Avoid hand touch to product, material or equipment.
- Hand washing.
- Special requirements for special groups of products.

11. Principles of Good Manufacturing
Practice
1. Quality management.
2. Personnel.
3. Premises and equipment
4. Documentation
5. Production areas
6. Quality control
7. Contract manufacturing
8. Complaints and product recall
9. Self - inspection

12. Premises and equipment
• Premises and equipment must be located, designed, constructed,
adapted and maintained to suit the operations to be carried out.
• Layout and design must aim to minimize the risk of errors and
permit effective cleaning and maintenance in order to avoid cross-
contamination, build up of dust or dirt and any adverse effect on the
quality of products.
• Production, QC, storage, weighing, ancillary areas.
• Equipment

13. Principles of Good Manufacturing
Practice
1. Quality management.
2. Personnel.
3. Premises and equipment
4. Documentation
5. Production areas
6. Quality control
7. Contract manufacturing
8. Complaints and product recall
9. Self - inspection

14. Documentation
Documents required:
• Specifications for starting and packaging materials.
• Specifications for intermediate and bulk products.
• Specifications for finished products.
• Manufacturing formula.
• Manufacturing process and instructions.
• Packaging instructions.
• BMR
• Batch packaging records.

15. Procedures and Records:
• Receipt.
• Sampling.
• Testing.
• Rejection.
• Distribution.
• Cleaning.
• Log books.
• Validation, calibration, maintenance and sanitization,
personnel activities, environment control, pest control,
complaints, recalls, returns.

16. Principles of Good Manufacturing
Practice
1. Quality management.
2. Personnel.
3. Premises and equipment
4. Documentation
5. Production areas
6. Quality control
7. Contract manufacturing
8. Complaints and product recall
9. Self - inspection

17. Production
• Clearly defined procedures.
• Supervised by competent people.
• Incoming materials should be checked and containers should be
cleaned and labelled with prescribed data.
• Damaged containers should be reported.
• Quarantined until release.
• Appropriate storage conditions, batch segregation and stock rotation.
• Sampling should not induce cross-contamination or mix-up.
• Prevent microbial contamination at any stage.
• Avoid generation of dust.
• Materials, containers, equipment and rooms should be labelled.
• Labels may be coloured to indicate the stage.

18. • Correct process flow and personnel flow.
• Production area should not be accessible to other workers.
• Production of non-medicinal is not allowed in equipment used
for medicinal products.
• No deviation in procedures.

19. • Prevention of cross-contamination, dust, clothing and residues.
• Process validation and revalidation.
• Starting material should be purchased from approved suppliers
with relevant specifications.
• Starting materials to be used should be released by QC.
• Intermediate or bulk products should be kept in appropriate
validated conditions and being recorded.
• Primary packaging material should be treated as the starting
materials.( avoid mix-up)
• Physical segregation of different products online with printing.
• Finished product should be quarantined until QC release.

20. Principles of Good Manufacturing
Practice
1. Quality management.
2. Personnel.
3. Premises and equipment
4. Documentation
5. Production areas
6. Quality control
7. Contract manufacturing
8. Complaints and product recall
9. Self - inspection

21. Quality Control
• QC is concerned with sampling, specifications as well as
organization and release procedures to ensure that necessary
relevant tests are carried out.
• Should be independent from production.
• Managed by qualified experienced person.
• Good laboratory practice.
• Documentation.
• Reference samples.
• Validated testing methods.
• Reagents and reference standards.
• IPC
• On-going stability program.

22. Principles of Good Manufacturing
Practice
1. Quality management.
2. Personnel.
3. Premises and equipment
4. Documentation
5. Production areas
6. Quality control
7. Contract manufacturing
8. Complaints and product recall
9. Self - inspection

23. Contract Manufacturing
• Contract giver.
• Contract acceptor
• Contract

24. Principles of Good Manufacturing
Practice
1. Quality management.
2. Personnel.
3. Premises and equipment
4. Documentation
5. Production areas
6. Quality control
7. Contract manufacturing
8. Complaints and product recall
9. Self - inspection

25. Complaints and product recall
• Any complaint concerning a product defect should be recorded
with all original details and thoroughly investigated.
• QC should study the problem.
• Recall for a batch carried out by other department rather than
the marketing and sales.
• Written procedures should be followed.
• Marketing authority should be informed.
• Recall products should be stored separately.
• Problem should be investigated and reported.

26. Principles of Good Manufacturing
Practice
1. Quality management.
2. Personnel.
3. Premises and equipment
4. Documentation
5. Production areas
6. Quality control
7. Contract manufacturing
8. Complaints and product recall
9. Self - inspection

27. Self inspection
• Self inspection should be carried out by a person from the
company or preferably from out side the company.
• Regular inspection and be recorded.
• Check list will be better.
• Corrective action should be taken for the observations.