Good Manufacturing Practices For Pharmaceutical Products


 2. Good Manufacturing Practices (GMP) For Pharmaceutical Products:

2.1   GMP is that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. GMP is concerned with both production and QC. GMP is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. Under GMP:

a)   All manufacturing processes are clearly defined, systematically reviewed for associated risks in the light of scientific knowledge and experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications;

b)   Qualification and validation are performed;

c)   All necessary resources are provided, including:

(i)   Sufficient and appropriately qualified and trained personnel,

(ii)   Adequate premises and space,

(iii)   Suitable equipment and services,

(iv)   Appropriate materials, containers and labels,

(v)   Approved procedures and instructions,

(vi)   Suitable storage and transport,

(vii)   Adequate personnel, laboratories and equipment for in-process controls;

d)   Instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided; 

e)   Procedures are carried out correctly and personnel are trained to do so;

f)   Records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of the product are as expected. Any significant deviations are fully recorded and investigated with the objective of determining the root cause and appropriate corrective and preventive action is implemented;

g)   Records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form;

h)   The proper storage and distribution of the products minimizes any risk to their quality and takes account of good distribution practices (GDP);

i)   A system is available to recall any batch of product from sale or supply;

j)   Complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products to prevent recurrence.

3. Sanitation and Hygiene:

3.1   A high level of sanitation and hygiene should be practiced in every aspect of the manufacture of medicines. The scope of sanitation and hygiene covers personnel, premises, equipment and apparatus, production materials and containers, products for cleaning and disinfection, and anything that could become a source of contamination to the product. Potential sources of contamination should be eliminated through an integrated comprehensive programme of sanitation and hygiene. (For Personal hygiene see section 11, and for sanitation see section 12, “Premises”.)

WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles

(Annex 2, WHO Technical Report Series 986, 2014)

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