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Good distribution practice is a set of standards for the sourcing, handling, storage, and transportation of medicines for human use and their active ingredients. Wholesale licence and authorisation holders must comply with good distribution practice to ensure the quality, safety, and security of medicinal products throughout the pharmaceutical supply chain.

Why is Good Distribution Practice Important?

Good distribution practice is important because it greatly affects public health. Any mistake in distribution can cause shortages, delays, and even the introduction of falsified medicines into the market.

Another reason why GDP is important in pharma is that it aids in product traceability, which can be a huge factor during official investigations of quality issues or incidents involving pharmaceutical products. Overall, following good distribution practices protects wholesale distributors from situations that would not only damage their reputation in the industry but also harm the general public and lead to a huge loss in customers.

Who Needs GDP audit?

According to the European Medicines Agency, all wholesale distributors of medicines in the European Economic Area (EEA) need GDP certification. Similarly in the UK, anyone that intends to sell or supply medicines to someone other than the end-user needs GDP certification. In the European Union (EU), a GDP certificate is issued by the competent authority when the inspection has officially ended or 90 days since the last day of the inspection, provided that nearly all areas are GDP compliant. Good distribution practice in the UK is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). Unlike in the EU, the GDP certificate is only given when the MHRA inspector accepts the distributor’s response to the post-inspection letter.

GDP (Good Distribution Practices) Food Safety Audit – Companies turn to CDG to ensure their food safety policies and procedures are defined and implemented through third party, independent verification.

Why GDP Safety Audit?

A GDP safety audit helps ensure that the products you are storing and transporting are safe for human consumption. It requires knowledgeable food safety professionals to make a dedicated effort to ensure food safety polices and procedures are in place and enforced. A GDP safety audit is a stepping stone to preparing your company for accredited certification to various certifications.

Companies who complete a CDG GDP audit will benefit from:

GDP Guidelines or Principles of Good Distribution Practice

The following GDP guidelines are based on the World Health Organization (WHO) Good Distribution Practices for Pharmaceutical Products and the European Commission (EC) Guidelines on Good Distribution Practice of Medicinal Products for Human Use:
Third party, independent verification of processes/procedures
Validating effective and proper allergen management – the #1 cause for recalls Ensured adherence to applicable prerequisite programs
Strengthened programs for compliance to regulatory requirements
Showing due diligence to provide safe products to consumers
Quality System/Quality Management

A quality system should have the organizational structure, procedures, processes, resources, and actions needed to demonstrate that the distributor meets quality requirements. Quality management or the quality system must include a documented quality policy as well as authorized procurement and release procedures. Wholesalers are also required to assess potential risks to the quality of products and follow quality risk management principles. Quality systems should be regularly reviewed and revised according to the recommendations of the risk assessments conducted.

About CDG

CDG is one of very few inspection accredited (ISO 17020 accredited by ILAC channel) agencies in India. We conduct food safety or food hygiene inspections.