ALL

ABOUT

GMP

WHAT IS GMP
Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality appropriate to their intended use and as required by the Marketing Authorization or Product Specification.

WHY TO FOLLOW GMP

TO ENSURE PRODUCTS ARE FIT FOR THEIR INTENDED USE PRODUCTS COMPLY WITH THE REQUIREMENTS OF MARKETING AUTHORISATION/SPCIFICATION PRODUCTS DO NOT PLACE PATIENTS AT RISK DUE TO INADEQUATE SAFETY , QUALITY AND EFFICACY

WHO ARE INVOLVED

Designing and Implementation System is the responsibility of : SENIOR MANAGEMENT OF THE FIRM Participation and commitments remain with : STAFF MEMBERS OF THE FIRM AT ALL LEVELS SUPPLIERS DISTRIBUTORS

BASIC REQUIREMENTS OF GMP

Clearly

defined, systematically reviewed(in the light of experience) manufacturing processes. Such processes are capable of consistently manufacturing medicinal products of required quality. Well validated manufacturing processes with appropriate Change Control Procedure. All necessary facilities for GMP are provided including

GMP FACILITIES.
Appropriately qualified and trained personnel Adequate premises and space Suitable equipment and services Correct materials, containers and labels

GMP FACILITIES..

Approved procedures and instructions

Suitable storage and transport.

GMP FACILITIES..
Instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided; Operators are trained to carry out procedures correctly; Records are made, manually and/or by recording instruments, during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and then the quantity and quality of the product was as expected.

GMP FACILITIES..
Any significant deviations are fully recorded and investigated; Records of manufacture including distribution which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form; A system is available to recall any batch of product, from sell or supply;

GMP FACILITIES.
Complaints about marketed products are examined, causes of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent reoccurrence.

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MATERIAL Contd.
Botanical name of the plant Details of source Method of collection/cultivation harvesting Brand and quantity of pesticides applied [WHO guideline on Good Agricultural & Collection Practices] Whole plant/part of plant /if dried drying system Description [ Macroscopic/microscopic ]; Identification test Assay procedure;Limit tests Method of determination of pesticide contamination with acceptance limits;Test for toxic metals and likely contaminants/foreign materials/adulterants Test for microbial contamination/fumigant residues[if applicable], mycotoxins, pest-infestation, radioactivity & their acceptable limits Other appropriate tests Reference of any Pharmacopoeial monograph Starting material derived from or accompanying genetically modified organism should comply national/international regulations and information should be included in the label

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Change Control Procedure --Change of quality of herbal medicine, particularly content of active ingredient. Additional test & validation studies to justify Change Control Critical process steps & Factors --Extraction time, temperature, solvent purity & acceptance criteria

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Herbal material -Potential for degradation, infestation with certain pests & sensitivity to microbial contamination Production area -Dedicated premises preferred -Special attention to control dust generation -Appropriate exhaust for heating/boiling operations -All precautions to avoid cross-contamination

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