Good manufacturing practice (GMP)

Definition: The part of quality assurance aimed at ensuring that products are manufactured to a quality appropriate to their intended use.

Purpose of GMP:

1. Improve drug product quality.

2. Improve performance of manpower.

3. Improve image of Arab pharmaceutical industry.

4.  Lead to international

recognition

I)  General Guidelines:

1. Outline the steps which should be taken by manufacturers            ensuring that their drug products are the quality intended.

2.  The manufacturing process depends collectively on starting material, production, buildings, equipment, personal…… etc.

3.  All drug products should be manufactured under carefully controlled& monitored condition.

II) Definitions:

All terms involved in the drug manufacturing process are defined to avoid any mistake understanding or confusion e.g. material, manufacturing, Q.C………..etc.

III) Personnel:

All personnel employed in the pharmaceutical industry should receive basic training in area relative to their work and hygienic aspects.

Premises: V) I

Suitable location design & construction is required with attention directed to compatibility, adequacy & safety.

V) Sanitation:

Sanitary standards for the maintenance of manufacturing premises are specified & written instructions for sanitary procedures.

VI) Equipment:

Design & construction of equipment should be

1.  Ease of clean & reduce contamination.

2.  Location.

3.  Balance calibration & equipment monitors

4.  Suitable for the purpose.

VII) Starting material:

Requirement of starting materials include:

Proper record & identification.  •

• Sampling, analysis, quarantine & storage.

Only authorized personnel are responsible for dispensing of these materials.

VIIIA) Production: essential to provide products which conform to required specification.

• Processing: include evaluation of defined procedure & stability data also records & labeling policies should be defined.

• Packaging: storage & handling of material need to document & check to prevent any errors.

• Cleanliness: checks are required to ensure cleanliness &/or sterilization.

• Equipment & containers: these need to be identified & labeled.

VIIIB) sterile Production: should be manufactured with elimination microbial & contamination under monitored conditions.

• Personnel: should be healthy, clean & well trained

• Clothing: Special cloths are used.

• Premises: temperature & humidity controlled.

• Processing: should be validated.

• Sterilization.

IX) Quality control: is required to assure that products are manufacture according to specific condition.

 X) Documentation: the system consists of instructions, description, specification & records.

X I) Self-inspection: for the purpose of annual review of the status of the manufactures with GMP.

Include: personnel, premises, production, packaging & Q.C.

  X II) Complaints: should be recorded, evaluated & investigated.

X III) Returned & salvaged drug products: These products must be identified & either destroyed or salvaged according to established procedure.