Current Good Manufacturing Practice (cGMP) is the rigorous system and process that is legally required for the manufacture of all pharmaceutical products, including biopharmaceuticals and over-the-counter medicines.
cGMP requirements cover the manufacture and testing of pharmaceuticals or drugs, active pharmaceutical ingredients, diagnostics, foods, and medical devices.
Whilst there is no formal requirement to comply with cGMP during early clinical development in phase I and phase II clinical trials, cGMP must be fully implemented by phase III clinical trials and for all subsequent manufacturing activities.
cGMP regulations are extensively covered in many resources and therefore only summarised here. GMP regulations provide a detailed guide to the activities that must be performed to ensure pharmaceutical products are manufactured consistently.
Some specific areas covered include:
- Manufacture using quality systems managed by quality assurance
- Process validation
- Analytical validation
- Cleaning validation (equipment, facilities, etc.)
- Facilities and utilities validation
Standard guidance on cGMPs covering the EU, Japan and the US is covered under ICH (International Conference on Harmonisation) regulations. Local guidance is also available, in the UK Orange Guide by the MHRA and in the US by FDA-21 CFR 210 Code of Federal Regulations.
cGMP applies to countries that are signatories to ICH, as well as countries that have adopted ICH guidelines, e.g. Australia, Canada, and Singapore.
The World Health Organisation (WHO) also has a mandated version of GMPs used by pharmaceutical regulators in over 100 countries worldwide. These cover the key elements of ICH, FDA, and MHRA GMPs but generally are less rigorous.
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Woodley BioReg holds a GMP licence (MIA and WDA) from UK’s MHRA and has extensive practical expertise of supporting pharmaceutical, biopharmaceutical, and healthcare manufacturers develop and implement cGMP systems globally.
This has included review and remediation of existing GMP standards, development and implementation of quality systems including Validation Master Plans, GMP training, GMP auditing including Pre-approval Inspection (PIA) and preparation of GMP standard documents such as SOPs, validation documents, and submission ready components.