How can a new pharmaceutical company get its first GMP Certificate in Kenya?
Gmp Certification in Kenya(Good Manufacturing Practices, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
GMP defines quality measures for production and quality control and establishes general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented and that the personnel, premises, and materials are suitable for the production of pharmaceuticals and biologicals including vaccines. GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.
How can a new pharmaceutical company apply for its first GMP Certificate in Kenya?
These are the stages involved in applying for a Good Manufacturing practice certificate.
Step 1 – make a formal application in writing for a certificate of Good Manufacturing Practice and apply to the Pharmacy and
Poisons Board offices. A Company Medical representative shall send an application to the registry of Pharmacy and Poisons Board applying for a certificate of good manufacturing practice attaching the required documentation showing measures in place of safeguarding the health of patients as well as producing good quality medicine, medical devices, or active pharmaceutical products. These inspections are conducted to verify compliance with GMP which is a requirement for the issuance of an establishment license.
Step 2- Attach the required documents
Here you are required to present the necessary documents issued by the competent Health Authority in the country of manufacture. These documents differ in some aspects depending on the class of product you want to register. for more information
- Some of the documents include Power of Attorney or contract manufacturing Agreement;
- Manufacturing license and free sale certificate,
- Trademark registration, certificate of incorporation/business name, and many more.
Note: All the necessary documents must be found satisfactory before any other process can be carried out.
Stage Two – Drug production Evidence
There must be evidence that the food product is manufactured according to Good Manufacturing Practices (GMP). in the case of imported drug product
Guidelines to get GMP Certification in Kenya:
They follow a few basic guidelines;
All guidelines follow a few basic principles:
- Hygiene: Pharmaceutical manufacturing facilities must maintain a clean and hygienic manufacturing area.
- Controlled environmental conditions to prevent cross-contamination of drug products from other drugs or extraneous particulate matter which may render the drug product unsafe for human consumption.
- Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
- Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
How to get GMP Certification in Kenya?
If you are having trouble putting this GMP Certification management system into practice or are unsure how to obtain GMP Certification in Kenya, get in touch with us at [email protected] or through www.Factocert.com that our consulting experts can provide you with an effective project plan.
Why pick Factocert to obtain GMP Certification in Kenya?
Factocert is amongst the very best GMP Certification specialists in Kenya. We provide along with offering the best GMP Certification. GMP needs, along with numerous other options likewise in Kenya, different other significant cities of Kenya with the option of application, documents, visit, qualification, audit, and likewise various other pertinent services all over the world at reduced.
GMP certification ensures that pharmaceutical production facilities have a complete traceability system that effectively traces any batch of drug or material back to its source, thus ensuring quality is consistently maintained throughout the entire process from beginning to end.