Introduction:
GMP Certification in Kenya, a good manufacturing practice (GMP) system, guarantees that goods are regularly produced and controlled following quality standards.
Good manufacturing practices aim to eliminate, minimize, and regulate physical, chemical, and biological risks in the processing environment.
Requirements of GMP Certification in Kenya:
- Personnel
- Grounds and Plants
- Sanitary Activities
- Sanitary Controls and Facilities
- Instruments and tools
- Procedures and Regulations
- Distribution and Storage
- Maintaining and Distributing
What paperwork is needed for GMP Certification in Kenya?
- Name of the applicant and contact information (phone, fax, email, etc.)
- a copy of the manufacturing permit.
- Products on the approved list.
- The Site Master file (as specified under WHO TRS 823).
- Information on the final formulation.
- Â Understand the production process and formula.
- The finished product’s description and the analysis method.
- Â Stability study evaluation (accelerated and real-time) for three batches, including information on batch size, batch number, production date, expiration date, and stability study circumstances.
- Report on the process validation for three batches.
- Â An analytical method validation report.
- List of technical staff, along with information about their training, expertise, and approval status.
- a list of the instruments and equipment
- SOPs and STPs list
- The layout of a manufacturing plant.
- Water system diagram with circulation loop and MOC specified.
- Product information sheet (as per Format B).
- Proof of effectiveness and safety following Rule 158B of the 1945 Drugs and Cosmetics Rules.
- Commitment to following domestic legislation, including the Drugs and Cosmetics Act of 1940 and its rules, the Drugs and Magic Remedies (Objectionable Advertisements) Act of 1954 and its rules, etc.
What Advantages Come with GMP Certification in Kenya?
While most manufacturers of pharmaceuticals and medical devices adhere to GMP Certification in Kenya, others have developed their standards following local laws.
- empower certification holders to choose quality creation, prompt detection of manufacturing and management problems, adherence to critical laws and regulations,
- enhancing overall credibility and public perception, lowering the risk of product quality and safety issues,
- boosts consumer trust in your products,
- reduces operating expenses resulting from rework and fines for non-compliance,
- aids in increasing export potential,
- reduced inspection overlap, and cost savings.
How much time does it take to become GMP certified?
The GMP Certification in Kenya standards is adopted by a manufacturer, who then makes the necessary modifications to comply with the standards. Depending on preexisting practices and conditions, this could take 3–12 months.
How can one obtain GMP Certification in Kenya?
Contact the best GMP Consultant in Kenya at contact@factocert.com or our website by visiting www.Factocert.com if you need assistance putting this GMP Certification management system into operation or have questions about how to get GMP Certification in Kenya so that our consulting professionals can give you a project plan that will work.
Contact now to get to know GMP Certification cost in Kenya. Factocert is the best GMP Certification body in Kenya and can assist you to get GMP Certification in Kenya.
Conclusion:
Additionally, it demonstrates that they create their products to the best quality feasible because of their solid reputation as a reliable and responsible facility. A manufacturer can ensure quality if they have a GMP certification and a product’s manufacturing location is confirmed by the FDA.
