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Good Manufacturing Practices

Good Manufacturing Practices (GMP) for Pharmaceutical Products

Good Manufacturing Practices is the part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.

Compliance with the Guidelines on Good Manufacturing Practices for Pharmaceuticals published by the World Health Organization (WHO) is the minimum GMP standard required for marketing authorization in Sri Lanka.

All local pharmaceutical manufacturering facilities are inspected at least once in every two years to assess the compliance with GMP. Currently, foreign manufacturers are only required to provide attestation by the competent authority in that country that a given product is manufactured in premises and using operating practices that conforms to GMP.

Criteria and mechanism for GMP inspection of foreign manufacturers are currently being developed.