GOOD MANUFACTURING PROCESS Provides a high level assurance that medicines are manufactured in a way that ensures their safety, efficacy and quality Medicines are manufactured to comply with their marketing authorization Quality is built in Testing is part of GMP, but alone does not provide a good level of quality assurance

1. Good Manufacturing Practise
By
Peramasani Naresh *
Ratnam institute of pharmacy
Pidathapolur, Nellore – 524346.
Under the Guidance of :
P.Rameeja

2. Good Manufacturing
Practices should follow:
1. Quality assurance
2. Good manufacturing practices for pharmaceutical
products
3. Sanitation and hygiene
4. Qualification and validation
5. Complaints
6. Product recalls
7. Contract production and analysis
– General
– The contract giver
– The contract accepter
– The contract

3. 8. Self-inspection and quality audits
– Items for self-inspection
– Self-inspection team
– Frequency of self-inspection
– Self-inspection report
– Follow-up action
– Quality audit
– Suppliers’ audits and approval
9. Personnel
– General
– Key personnel
10. Training
11. Personal hygiene
12. Premises
– General
– Ancillary areas
– Storage areas
– Weighing areas
– Production areas
– Quality control area

4. 13. Equipment
14. Materials
– General
– Starting materials
– Packaging materials
– Intermediate and bulk products
– Finished products
– Rejected, recovered, reprocessed and reworked materials
– Recalled products
– Returned goods
– Reagents and culture media
– Reference standards
– Waste materials
– Miscellaneous

5. 15. Documentation
– General
– Documents required:
• Labels
• Testing procedures
• Specifications for starting and packaging materials,
for intermediate and bulk products and for finished
products
• Master formulae and Batch Processing Records
• Packaging instructions and Batch Packaging
Records
• Standard Operating procedures (SOP's) and records
• Logbooks

6. Good Manufacturing
Practices (cont'd)
16. Good practices in production
– General
– Prevention of cross-contamination and bacterial
contamination during production
– Processing operations
– Packaging operations
17. Good practices in quality control
– Control of starting materials and intermediate, bulk and
finished products
– Test requirements
– Batch record review
– Stability studies

7. Inspect for GMP
• Verify compliance with GMP
• Verify compliance with marketing
authorization
– Dossier: "Dedicated equipment is used"
Inspection: Observation that this means "dedicated while
used for the product or not being used for another
product"
– Dossier: "The vials are removed from the lyophilliser and
crimped in a grade A environment"
Inspection: Correct, but before crimping they are stored
in an uncontrolled corridor

8. Nessicity of GMP
• Provides a high level assurance that medicines
are manufactured in a way that ensures their
safety, efficacy and quality
• Medicines are manufactured to comply with
their marketing authorization
• Quality is built in
– Testing is part of GMP, but alone does not
provide a good level of quality assurance

9. GMP is actually Good
Common Sense
Quality Management
Quality Assurance
GMP
Production and Quality Control

10. Quality management in
the drug industry
Philosophy and essential elements:
• "The concepts of quality assurance,
GMP, quality control and quality risk
management are interrelated aspects of
quality management, and should be the
responsibility of all personnel. ……their
relationship and their fundamental
importance to the production and
control of pharmaceutical products."

11. Quality Management
• The basic elements are:
– An appropriate infrastructure or “quality system”
encompassing the organization structure,
procedures, processes and resources
– The systematic actions necessary to ensure
adequate confidence that a product (or service)
will satisfy given requirements for “Quality”
The totality of these actions is referred to as
“Quality Assurance”

12. The five P's
• Premises
• Primary materials
• People
• Procedures
• Processes defined and recorded

13. Quality Assurance
• Quality assurance is a management tool
• In contractual situations, it also serves to generate
confidence in a supplier
• QA, GMP and Quality Control are interrelated aspects of
Quality Management
– They are described on the following slides in
order to emphasize their relationship and their
fundamental importance to the production and
control of pharmaceutical products

14. Quality Assurance
• Wide-ranging concept
– covers all matters that individually or collectively
influence the quality of a product
• Totality of the arrangements
– to ensure that the drug is continuously of the right
quality for the intended use
• Quality Assurance incorporates GMP
– and also includes product design and development,
with special focus on process design

15. Quality Assurance
means to assure:
• Products are designed and developed correctly
– Complying with, e.g. GMP, GCP, GLP
• Production and control operations are defined
• Managerial responsibilities are defined
– In job descriptions
• The manufacture, supply and use of correct starting
and packaging materials

16. Quality Assurance
includes:
• Responsibility of the Manufacturer for the quality of the
product
– Fit for intended use
– Comply with marketing authorization
– Safety, efficacy and quality
• Commitment of senior management and involvement of all staff
• Comprehensively designed and well implemented quality
system
• Full documentation and monitoring of effectiveness
• Competent personnel, sufficient premises, equipment and
facilities

17. Good Manufacturing
Practices
• That part of QA that ensures that products are
consistently produced and controlled
– Quality standards
– Marketing authorization
• Aim: Diminishing risks that cannot be controlled by
testing of product
– Contamination and cross-contamination
– Mix-ups (confusion)

18. Basic requirements for
GMP:
• Clearly defined and systematically reviewed processes
• Qualification and validation is performed
• Appropriate resources are provided:
– Qualified and trained personnel
– Premises, space, equipment and services
– Materials, containers, labels
– Procedures, storage, transport
– Laboratories and in-process control

19. GMP = continuous urge
for improvement
• Involvement of the management
• Annual Product Quality Review
• Quality risk management
• Complaints handling
• Self-inspection

20. Involvement of the
management
• The senior management is responsible to attain the
company's quality objectives
• All different departments and all levels within
departments should be involved; and it's the senior
management who should facilitate this
• Also suppliers and distributors should be involved
• The senior management should make available the
required resources
• The basis of the quality system is the quality statement
and quality policy, by the senior management

21. Product Quality Review
Objectives of Product Quality Review:
• To review and verify the consistency and
appropriateness of the existing process
• To identify and highlight any trends in
the process, e.g. in analytical results,
yields etc.
• To identify any possible product or
process improvements

22. Annual Product Quality
Review (cont'd)
• Review of Marketing Authorization variations
submitted, granted or refused (incl. third countries)
• Review of stability programme and trends
• Review of adequacy of previous decisions on changes
or improvements or corrective actions
• For new Marketing Authorizations (plus new
variations) a review of post marketing commitment
• The qualification status of all relevant equipment and
utilities (like water, HVAC, gases, etc.)
• Review of Technical Agreements (if applicable)

23. Complaints handling
Complaints: Principle
“All complaints and other information concerning potentially
defective products must be carefully reviewed according to written
procedures and corrective action should be taken.”
Complaints procedure :
• Designated responsible person:
– To handle complaint
– Decide on measure to be taken
– May be authorized person - if not, must advise authorized
person of results
– Sufficient support staff
– Access to records
• Written procedure (SOP):
– Describes action to be taken
– Includes need to consider a recall (e.g. possible product
defect)

24. Complaints Procedure
• Thorough investigation:
– QC involved
– With special attention to establish whether "counterfeiting" may have
been the cause
– Fully recorded investigation – reflect all the details
• Due to product defect (discovered or suspected):
– Consider checking other batches
– Batches containing reprocessed product
Self inspection :
• Purpose is to evaluate whether a company’s operations remain compliant with
GMP
• The programme should
– cover all aspects of production and quality control
– be designed to detect shortcomings in the implementation of GMP
– recommend corrective actions
– set a timetable for corrective action to be completed
• Should be performed routinely
• Also on special occasions such as
– Recalls
• Repeated rejections

25. Summary and conclusions:
• GMP compliance is not an option
• Quality should be built into the product
• GMP's are very similar and are really
Good Common Sense
• Good Practices cover all aspects of
manufacturing activities prior to supply
• The role and involvement of senior
management is crucial

26. Reference
• www.indianembassy.org/Econamic_News pdf
• www.ich.org 18 may 2007 pharmaceuticals of human use.
• grazal , J.G and D.S Earl (1997) quality assurence journal
2:55-60
• www.who.org/GMP
• www.wikipedia.com/difference between glp and gmp
• www.google.in/review articles on gmp.

27. P.NARESH