Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP)
Definition of GMP According to WHO
GMP stands for Good Manufacturing Practice. WHO defines the term “Manufacturing” as “all operations involved in the production of a drug, including processing, compounding, formulating, filling, packaging and labeling.” According to WHO, “Manufacturing practices which result in good quality finished products and has adequate consideration for the safety of the employees, is recognized as Good Manufacturing Practice.”
GMP regulations were promulgated by the US Food and Drug Administration (USFDA) under the authority of the Federal Food, Drug and Cosmetic Act. WHO draft text of GMP was adopted in 1967.
GMP is sometimes referred to as cGMP. Here “c” stands for “current” reminding manufacturer that they must employ methods and systems which are up-to-date to comply with the regulation.
Ten Golden Rules of GMP
1) Get the facility designed right from the start.
2) Validate process.
3) Write good procedure and follow them.
4) Identify who does what.
5) Keep good records.
6) Train and develop staff.
7) Practice good hygiene.
8) Maintain facilities and equipment.
9) Build quality into the whole product life cycle.
10) Perform regular audit.
Parameters of GMP
There are 17 parameters of GMP.
They are:
1) Quality Assurance
2) GMP for Pharmaceutical Products
3) Sanitation and Hygiene
4) Qualification and Validation
5) Complaints
6) Product Recall
7) Contract manufacturing and analysis
8) Self-inspection and quality audit
9) Personnel
10) Training
11) Personnel Hygiene
12) Premises
13) Equipment
14) Materials
15) Documentation
16) Good practice in production
17) Good practice in quality control
Functions should be performed to ensure GMP in a Pharmaceutical Plan
Following functions should be performed to ensure GMP in a pharmaceutical plan:
• All manufacturing processes are clearly defined and systematically reviewed to ensure the constant manufacturing of pharmaceutical products that comply with specifications.
• All necessary resources are provided e.g. qualified and trained personnel, adequate premises and space, suitable equipment, proper materials, approved procedures and instructions.
• Validation and qualification are performed.
• Records are made during every steps of manufacturing.
• Proper storage and distribution.
• A system is available for recall if necessary.
• Complaints about marketed products are examined, causes of a defect are investigated and measures are taken to prevent a recurrence.
Benefits of GMP/cGMP
Benefits of GMP include:
• They outline a Quality System that reduces or prevents errors.
• Ensure products are safe for use in humans.
• Prevent/control contamination and cross-contamination.
• Prevent mislabeling and adulteration.
• Minimize variations in potency of the drug.
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