Good Manufacturing Practices

Purpose and Principles of GMP

DIPSAR

MD. IMRAN MALIK(D.pharm, B.pharm- DIPSAR)

Persuing M.Pharm (Pharm. Management)New Delhi, 14 Aug, 2015

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GOOD MANUFACTURING PRACTICES

QUALITY OF DRUGS IS ESSENTIALLY THE RESPONSIBILITY OF MANUFACTURERS.

GMP GUIDELINES ARE A MEANS TO ASSURE THIS VERY QUALITY OF DRUGS.

GMP REGULATIONS WERE INTRODUCED IN THE FORM OF AMENDED SCHEDULE ‘M’ IN 1988.

PRINCIPLES OF GMP 1. General Requirements Location and surrounding Buildings and premises Water system Disposal of waste

2. Quality assurance (QA)

3. Sanitation and hygiene

4. Qualification and validation

5. Warehousing area

6. Production area

7. Ancillary areas

8. Quality control area

9. Personnel

10. Quality control area

11. Manufacturing operations and control

12. Raw materials

13. Documentation and records

14. Self inspection and quality audit

15. Specifications

16. Master formula records

17. Standard Operating Procedures (SOP)

GMP is actually Good Common Sense

Quality Management

Quality Assurance

GMP

Production and Quality Control

Quality Management:

What is Quality Management?

The aspect of management function that determines and implements the “quality policy”

The overall intention and direction regarding quality, as formally expressed and authorized by top management

Intermezzo: the five P's

Premises

Primary materials

People

Procedures

Processes defined and recorded

Quality Assurance

QUALITY ASSURANCE IS COMPANY BASED.

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

The position of QA

Director

QA

Production QC lab Other Depts

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

AIM OF 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)

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

Clear, written instructions and procedures

Trained operators

Records of actions, deviations and investigations

Records for manufacture and distribution

Proper storage and distribution

Systems for complaints and recalls

GMP = continuous urge for improvement

Involvement of the management

Annual Product Quality Review

Complaints handling

Self-inspection

Annual Product Quality Review

Objectives to do an Annual 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

Complaints handling “All complaints and other information concerning

potentially defective products must be carefully reviewed according to written procedures and corrective action should be taken.”

Investigation and evaluation should result in appropriate follow-up actions

All decisions and measures taken should be recorded Referenced in batch records Records reviewed - trends and recurring problems

Self-InspectionPurpose 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

Be performed routinely Also on special occasions such as

Recalls Repeated rejections When a GMP inspection is announced by the national drug

regulatory authority

Summary and conclusions:

GMP is mandatory in countries with a regulated pharmaceutical market, and in the WHO Prequalification Programme too.

GMP's are very similar, they are nothing but Good Common Sense Good Practices cover all aspects of company's activities prior to sales GMP is not a reward, nor an external assignment, it should be built into the

company Just like quality, which should be built into the product The role and involvement of senior management is crucial GMP means an urge for continuous improvement, 3 of the tools to do so are:

Annual Product Quality Reviews Complaint handling and trending Self-inspection

THANK YOU