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How to Apply for Certifcate of Good Manufacturing Practice in Kenya

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How to Apply for Certifcate of Good Manufacturing Practice in Kenya by Kenyans247(1): Sun Jan 2020 01:42pm
Procedure
Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a drug product is safe for human consumption. Many countries have legislated that pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.


In Kenya the GMP is enforced by SGS Kenya which is a world leader in third party certification and verification. They help to ensure that regulatory compliance is followed while demonstrating knowledge of the importance of producing and trading safe, quality food.

They follow the few basic guidelines;

All guidelines follow a few basic principles:

Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.
Controlled environmental conditions in order to prevent cross contamination of drug product from other drug 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.
Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
Operators are trained to carry out and document procedures.
Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
The distribution of the drugs minimizes any risk to their quality.
A system is available for recalling any batch of drug from sale or supply.
Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
Practices are recommended with the goal of safeguarding the health of patients as well as producing good quality medicine, medical devices, or active pharmaceutical products. In Kenya, a drug may be deemed "adulterated" if it has passed all of the specifications tests, but is found to be manufactured in a facility or condition which violates or does not comply with current good manufacturing guideline. Therefore, complying with GMP is mandatory in pharmaceutical manufacturing.

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 submit the application to 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 document 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 the compliance with GMP which is a requirement for the issuance of an establishment licence.

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 aspect depending on the class of product you want to register.

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 Practice (GMP). in the case of imported drug product

Eligibility
All food manufacturers companies both local and international in Kenya are Eligible for this certificate.

Instructions
The Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area at all times.
There must be policies in place to Control environmental conditions in order to prevent cross contamination of drug product from other drug or extraneous particulate matter which may render the drug product unsafe for human consumption.
The Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
The Manufacturing processes must be controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
Operators are trained to carry out and document procedures.
Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
The distribution of the drugs minimizes any risk to their quality.
A system is available for recalling any batch of drug from sale or supply.
Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.

Required Information
The key information required is as follows

1. Application should be on Good manufacturing practice single product basis toensures the integrity of your food manufacturing process as well as your compliance with food safety regulations.

2. Written application stating name of manufacturer and name (and brand, if applicable) of product to ensure of the safety and quality of food.

3. Completed Central Administration for Pharmaceutical Affairs General Inspection Department application form.

4. Certificate of Incorporation with the registrar of companies, if a company

5. Five (5) copies of the product dossier

6. Three (3) packs of the products samples

7. Notarized original copy of the duly executed Power of Attorney from the product manufacturer (imported product)

8. Certificate of Manufacture issued by the competent health or regulatory authority in country of origin and authenticated by the Egyptian Mission in that country (if foreign import). Where there is no Kenya mission, The British High Commission or an EAC country Mission will authenticate.

9. If contract-manufactured, Contract Manufacturing Agreement, properly executed and notarized by a Notary Public in the country of manufacture.

10. Current World Health Organization Good Manufacturing Practice Certificate for the manufacturer, authenticated by the Kenyan Mission.

11. Certificate of Pharmaceutical Products (COPP) duly issued and authenticated

12. Current Superintendent Pharmacists license to practice issued by the Kenya Pharmaceutical and poison board.

13. Premises Registration License from Kenya Pharmaceutical and poison board.

14. Certificate of Registration of brand name with trademark registry in the Ministry of Finance in Kenya

15. Letter of invitation from manufacturer to inspect factory abroad, stating full name and location of plant.

16. The applicable fee payable only if documents are confirmed to be satisfactory. Nutriceuticals, medical devices and other regulated drug products have similar requirements, with minor variations. Specific details can be obtained from PCPB.

Need for the Document
Good Manufacturing Practices (GMP) are the part of quality assurance that ensures that drugs are consistently produced and controlled in such a way to meet the quality standards appropriate to their intended use, as required by the marketing authorization.

Good manufacturing practices (GMP) are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.


Good Manufacturing Practices are a set of regulations, codes, and guidelines for the manufacture of:

Drug substances and drug products in Kenya
Medical devices in Kenya
In vivo and in vitro diagnostic products in Kenya
Foods in Kenya.
Good Laboratory Practice
Good Manufacturing Practice (GMP) is a vital component of Quality Assurance which helps to ensure that medicinal products are consistently produced with the quality standards appropriate for their intended use. Under the Medicines Act, all manufacturers and assemblers of medicinal products (both "Western Medicines" and "Herbal Medicines" (CPM)) are required to conform to GMP.

Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a drug product is safe for human consumption.

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