Every manufacturer wants to expand their business horizons. They wish to sell their products across the globe. However, different countries have different regulatory requirements for the firm’s to follow if they wish to sell their products in that particular country. In such scenarios WHO GMP and EU GMP certification schemes have helped them to meet the requirements of the majority of the countries. These certifications are issued by the Government of India after thorough joint inspection.
Recently, a surge has been observed w.r.t. number of manufacturers intending to achieve the alluring WHO GMP and/ or EU GMP certification for their manufacturing plants.
We at API First guide our clients through the complete certification process. The guidance process and services offered varies from company to company, however, basic inclusions are as follows:
- Internal audit
- Gap analysis
- Gap assessment
- Planning for gap redressal
- Support in gap closures as per Quality Management Systems and their documentation
- Facility up-gradation if any
- Layout modifications if any
- Preparation of application and dossier for WHO GMP and EU GMP certification
- Training of staff
- Pre-audit Inspection
- Preparing responses or compliance report for the observations raised by the Inspecting Authority.
