Good manufacturing practice (GMP) is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products and medical devices.
GMP Certification confirms the products identity, composition, quality, purity and strength which they represent in the market. Under it, there is a set of guidelines that offer a system of procedures and documentation by which the confirmation of the products are given.
Basic Rules of GMP:
1. Make sure you have the correct written instructions before starting a task.
2. Do not carry out a task for which you have not been trained or in which you do not feel competent.
3. Always follow instructions precisely. Do not cut corners. If in doubt, ask.
4. Check that the equipment and the materials that you are using are the correct ones, as stated in the procedure.
5. Check that the equipment you are using is clean.
6. Always be on your guard for labelling errors.
7. Keep everything clean and tidy (including yourself!).
8. Always be on the lookout for mistakes, defects and unusual events. Report them immediately.
9. Make clear accurate records of what was done and the checks carried out.
Good Distribution Practice (GDP) is a vital component of Quality Assurance. It requires the company to establish a quality system to ensure that products are consistently stored and handled as required by the marketing authorization or product specification, thereby maintaining the quality of the products during storage, transportation and distribution to be made clearer,it has recently been revised to include guidelines on the control and management of such products. Sections of the guidelines pertaining to the handling of cold chain products were revised based on established international standards and industry best practices.
Audit & Licensing Division - GMP and GDP Audit
The Audit & Licensing Division (ALD) comprises of Audit Branch (AB) and Licensing & Certification Branch (LCB). The principal function of the ALD is to audit and license pharmaceutical manufacturers and importers/wholesale dealers of Health Products in accordance with current international Good Manufacturing Practice (GMP) and the relevant Good Distribution Practice (GDP) standard respectively.
The objective of audit and licensing activities is to ensure the production of good quality medicines and the preservation of product quality down the supply chain from the manufacturers to the distributors and pharmacies.
Licences & Certificates
The types of licences and certificates under the purview of Audit & Licensing Division include:
GMP Consultants by State