topic 1-gmp overiew of concept

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES HYDERABAD, 10-18 NOVEMBER 2003 HYDERABAD, 10-18 NOVEMBER 2003 WHO SEARO Good Manufacturing Practice Overview of concept WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES HYDERABAD, 10-18 NOVEMBER 2003 By: Alireza Khadem

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Page 1: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

Good Manufacturing PracticeOverview of concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION

FOR VACCINESHYDERABAD, 10-18 NOVEMBER 2003

By: Alireza Khadem

Page 2: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

Objectives of the workshop

• Ensure that NRA will be able to conduct adequate GMP inspections – All GMP inspectors supervising EPI vaccine manufacturers will

improve their skills in conducting competent and efficient GMP inspections

– identify GMP experts that can participate/facilitate in international peer review audits or GMP training/follow up

• Develop a plan to ease enforcement of GMP in all EPI vaccine manufacturers – training of QA managers in self inspection– Follow up and monitoring of GMP audits findings

Page 3: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

Expected outcome at the end of the workshop

• A workplan to ease enforcement of GMP in by the NRA

• A workplan to implement and improve GMP in all EPI vaccine manufacturers

• A short term and long term training development plan of GMP inspectors and QA managers

• Identify the best resources persons to participate in WHO GMP audits or GMP training

Page 4: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

Organization & method of work

• 10-18 November, 8.30 am -5.30 including coffee break and lunch

• Evaluation of knowledge before, during and after the workshop

• Lectures based on need assessment• Mock audit in two facilities (15,16 Nov)• Work plan at the end of the workshop• Plenary and working group sessions

Page 5: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

Why GMPPatients taking medicines have very little

chance of detecting if anything is wrong

If something is wrong it can be very dangerous

The doctor, pharmacist and patient, all trust those who manufactured and packaged the product

Page 6: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

History of GMP

 Thorough investigations following this incident, it become very

probable that batches of the vaccine were contaminated with the so-called Kiel-strain

251 vaccinated72 deaths because of tuberculosis135 developed clinical tuberculosis44 survived

1930 Lubeck – BCG Vaccine

Page 7: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

History of GMP

 The "miracle drug" came into use.  It was marketed as a pediatric elixir.  

It  was  a  raspberry  flavoured  solution  in  a  liquid  industrial  solvent, etheylene  glycol.    Generally  an  elixir  is  designated  as  an  alcohol based  product,  but  this  particular  formulation  was  of  dietheylene glycol.   Upon  ingestion,  ethylene  glycol was metabolized  to  oxalic acid.

358 poisonings 107 deaths 251 sick but survived

1938 - Sulphanilamide, the elixir of death

FDCA-1938

Page 8: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

History of GMP1962- Thalidomide1962- Thalidomide

thousands of babies were born without arms or legsthousands of babies were born without arms or legs

Reason

One enantiomer caused sedation which was the desired effect, One enantiomer caused sedation which was the desired effect, while the other enantiomer caused devastating birth defects while the other enantiomer caused devastating birth defects known as Phocomelia. Solution was to remove the undesired known as Phocomelia. Solution was to remove the undesired enantiomer by a validated purification process assured by Assay enantiomer by a validated purification process assured by Assay Validation. Again, GMP deficiency by not having adequate QA Validation. Again, GMP deficiency by not having adequate QA and QC programmes which could have answered assay and QC programmes which could have answered assay validation. This led to guidelines on the development of New validation. This led to guidelines on the development of New Stereoisomeric Drugs (1992) US FDA.Stereoisomeric Drugs (1992) US FDA.

Drugs must be effective & safe

Page 9: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

1955 - Polio Vaccine (Cutter Labs, USA)   (Lambert, E.C., Medical Mistakes, Indiana University Press, 1978)

History of GMP

51 Children paralysed51 Children paralysed10 Deaths10 DeathsSeveral possible reasons:Several possible reasons:

Inconsistent viral inactivation process.Inconsistent viral inactivation process. ·Quick scale-up production without proper validation of inactivation ·Quick scale-up production without proper validation of inactivation step.step. ·Active live virus production process used heat inactivation step. ·Active live virus production process used heat inactivation step. • For virus; scale-up of heat inactivation step may not have been For virus; scale-up of heat inactivation step may not have been sufficient.sufficient.

Batch release

Page 10: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

History of GMP

WH0-GMP

EC-GMP

FDA-Aseptic Processing

FDA-cGMP

FDA-GMP

PIC-GMP

GMP Enforcement byGerman National Law

1968 1971 1978 1983 1985 1987 1989

Page 11: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

History of GMP

PIC-Adapts GMPAccording to EC-GMP

WHO-Revised GMP

WHO-GMP forBiological products

WHO-Guide for Inspection

Revision to Annex 1 EC-GMP

WHO-GMP for Sterile pharmaceuticals

1992 1992 1992 1996 1997 2002 2003

WHO-Revised GMP

Page 12: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

What is GMP?

Page 13: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

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…More Paper…More Work…More Cost…More Headache

Page 14: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

Quality Management• Determines and implements the “quality policy”• The basic elements are:

– an appropriate infrastructure or “quality system” encompassing the 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 termed “Quality Assurance”

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

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• Quality management is defined as the aspect of management function that determines and implements the quality policy.

• The quality policy is a statement by the top management of the company of its overall intentions and direction relating to quality, formally expressed as a corporate policy.

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

Quality Management• Terminology may differ

– “Quality System” is said to be rarely used in drug manufacturing

• The concepts of 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

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

There are two basic elements of this aspect of the management function of a pharmaceutical company:

• A working infrastructure = quality system. This includes:– Organizational structure– Procedures– Processes– Resources

• Systematic actions to bring the quality policy to life. The totality of these actions is termed quality assurance (QA).

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

Quality Relationships

Quality Management

Quality Control

GMP

Quality Assurance

Management AspectQuality systemQuality Policy…

PersonnelTrainingValidationSelf inspection

Quality ObjectiveQuality Manual

SamplingSpecificationsTesting

Page 19: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

Principles of 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 of the right quality for the intended use

• Quality Assurance incorporates GMP– and also product design and development

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

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• Inside an organization, QA is a management tool. In contractual situations, it provides confidence in the supplier.

• QA is not the duty of one organizational unit in the company alone, but is the responsibility of all staff members who in any way can influence product quality.

Principles of Quality Assurance

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

Requirements for QA Systems – I

1. Ensure products are developed correctly2. Identify managerial responsibilities3. Provide SOPs for production and control4. Organize supply and use of correct

starting materials5. Define controls for all stages of

manufacture and packaging

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

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Requirements for QA Systems – II

6. Ensure finished product correctly processed and checked before release

7. Ensure products are released after review by authorized person

8. Provide storage and distribution 9. Organize self-inspection

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

GMP

• Ensure that products are consistently produced and controlled

• Diminishes risks that cannot be controlled by testing of productCross-contaminationMix-ups

Page 24: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

What is Good Manufacturing Practices (GMP)?

World Health Organization defines GMP as: ”that part of quality assurance 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”

Page 25: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

Quality Standards

WHO GMP

National GMPPharmacopeias

Inspection

Marketing Authorization

NRA NCLDRA

Page 26: Topic 1-GMP Overiew of Concept

WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

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Basic Requirements for GMP – I

1. Clearly defined and systematically reviewed processes

2. Critical steps validated3. Appropriate resources: personnel,

buildings, equipment, materials4. Clearly written procedures 5. Trained operators

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

Basic Requirements for GMP – II

6. Complete records, failure investigations

7. Proper storage and distribution 8. Recall system9. Complaint handling

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

Defined Processes Premises Validated

Processes

Complaints andRecalls

WrittenProcedures and

Records

TrainedPersonnel and

Hygiene

Laboratories and Validated Tests

Contract production

and analysis

Materials andStorage

Equipments

What aspects of manufacturing does GMP cover?What aspects of manufacturing does GMP cover?

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

SEARO

Quality Control (QC) Department

• Each holder of a manufacturing authorization should have a QC Department

• Independence from production and other departments is considered to be fundamental

• Under the authority of an appropriately qualified and experienced person with one or several control laboratories at his or her disposal.

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

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Basic Requirements for Quality Control

Resources

• Adequate facilities• Trained personnel• Approved procedures

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

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Basic Requirements for Quality Control

Tasks• Sampling• Inspecting• Testing• Monitoring• Releasing/rejecting

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

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Basic Requirements for Quality Control - I

Objects• Starting materials• Packaging materials• Intermediates• Bulk products• Finished products• Environmental conditions

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

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Basic Requirements forQuality Control – II

1. Sampling approved by QC department2. Validated test methods3. Records4. Review and evaluation of production

documentation5. Failure investigations for all deviations 6. Ingredients comply with the marketing

authorization

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

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Basic Requirements for Quality Control – III

7. Ingredients are of the required purity8. Proper containers9. Correct labelling10. Release of batches by the authorized

person11. Retained samples of starting materials

and products

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HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

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Other Duties of the Quality Control Department

1. Establish QC procedures2. Reference standards3. Correct labelling 4. Stability testing 5. Complaint investigations6. Environmental monitoring

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Assessment of Finished Products

Should embrace all relevant factors. For example:

• production conditions• in-process test results• manufacturing documentation• compliance with finished product specification• examination of the finished pack

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

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Other Issues

• GLP• GEP• GCP• GSP• GDP

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WORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINESWORKSHOP ON GOOD MANUFACTURING PRACTICES (GMPs) INSPECTION FOR VACCINES

HYDERABAD, 10-18 NOVEMBER 2003HYDERABAD, 10-18 NOVEMBER 2003WHO

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Case study

• List the most important barriers or Inhibitors against to Implement GMP