Nigeria - Apply for Good Manufacturing Practice Certificate
- 1 Procedure
- 2 Required Documents
- 3 Office Locations & Contacts
- 4 Eligibility
- 5 Fees
- 6 Validity
- 7 Documents to Use
- 8 Sample Documents
- 9 Processing Time
- 10 Related Videos
- 11 Instructions
- 12 Required Information
- 13 Need for the Document
- 14 Information which might help
- 15 Other uses of the Document/Certificate
- 16 External Links
- 17 Others
Good Manufacturing Practices are enforced in Nigeria by SGS Nigeria 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.
- These are the stages involved in applying for a Good Manufacturing practice certificate.
- Stage one - Documentation
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 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 products (from foreign country),The importer must submit evidence that they are licensed to manufacture Food products for sale in the country of origin.
- Stage Three - Authenticated from Health Authority
There must be evidence by the competent Health Authority, that the sale of the product does not constitute a contravention of the food laws of that country. i.e.Certificate of Pharmaceutical Product (COPP) that conforms to WHO format.The documents in respect of C1-3 shall be authenticated by the Nigerian Mission in that country. In countries where no Nigerian Embassy or High Commission exists, any other Embassy or High Commission of any Commonwealth or West African country can authenticate.
- Stage Four - Dossier
The applicant shall submit two (2) dossiers made out in accordance with the Agencys format.
- Stage Five
Evidence of Trade Mark Approval for brand name from Federal Ministry of Commerce in Nigeria should be submitted.
- Stage Six - Annual License to practice Pharmacist
Copy of current Annual License to Practice as a Pharmacist for the Superintendent Pharmacist issued by Pharmacists Council of Nigeria should be submitted.
- Stage seven - Certificate of registration
Copy of Current Certificate of Registration Retention of Premises issued by Pharmacists Council of Nigeria.
- Stage Eight - Comprehensive Certificate of Analysis
Comprehensive Certificate of analysis of the batch of food product submitted for registration processing shall be submitted.
- Stage Nine
After all the documents have been submitted ,a drug product can not be manufactured in Nigeria, unless the factory is inspected and Certificate of Recognition is issued by NAFDAC. Then a certificate of Good manufacturing practice is issued.
1). Copy of permit and receipt (One copy)
2)Dossier formated according to NAFDACs requirements (one copy).
3)Vetting Samples (Three of each product)
4)Copy of Current Certificate of Registration Retention.
5)The documents in respect of C1-3
6)There must be evidence by the competent Health Authority.
7)Comprehensive Certificate of analysis
Office Locations & Contacts
Please list down the office locations that can be approached for applying. External links can also be used for specifying office locations.
All food manufacturers companies both local and international in Nigeria are Eligible for this certificate.
All payments to the Agency are payable by bank draft to the National Agency for Food and Drug Administration and Control.One million naira (=N=1,000,000:00) plus 5%
- A successful application attracts a Certificate of Registration with a validity period of five (5) years.
Documents to Use
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The time line for Good manufacturing practice certificate in Nigeria from registration to submission up to issuance
Videos explaining the procedure or to fill the applications. Attach videos using the following tag <&video type="website">video ID|width|height<&/video&> from external websites. Please remove the "&" inside the tags during implementation. Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, sevenload, viddler, vimeo, youku, youtube width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed. e.g In the following url "http://www.youtube.com/watch?v=Y0US7oR_t3M" Video ID is "Y0US7oR_t3M".
- 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.
Issued by the relevant health/regulatory body b)Authenticated by the Nigerian Embassy in the country of origin. In countries where no Nigerian Embassy exists, British High Commission or any Commonwealth or ECOWAS country commission can authenticate.
The key information required is as follows:
1. Application is on Good manufacturing practice single product basis
2. Written application stating name of manufacturer and name (and brand, if applicable) of product.
3. Completed NAFDAC application form (Form D-REG/001)
4. Certificate of Incorporation with the Corporate Affairs Commission, if a company
5. Five (5) copies of the product dossier
6. Three (3) packs of the products samples
7. Notarised 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 Nigerian Mission in that country (if foreign import). Where there is no Nigerian mission, The British High Commission or an ECOWAS 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 Organisation Good Manufacturing Practice Certificate for the manufacturer, authenticated by the Nigerian Mission.
11. Certificate of Pharmaceutical Products (COPP) duly issued and authenticated
12. Current Superintendent Pharmacists license to practice issued by the Pharmaceutical Council of Nigeria
13. Premises Registration License from Pharmacists Council of Nigeria (PCN)
14. Certificate of Registration of brand name with trademark registry in the Ministry of Commerce here in Nigeria
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 NAFDAC.
Need for the Document
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.
Regulatory agencies in Nigeria are legally entitled to conduct unannounced inspections a Good Manufacturing Practices (GMP) certification if they believe there are suitable grounds for doing so.These regulatory agencies include HACCP, ISO 22000, SQF and ISO 9001.
All food manufacturers in Nigeria are legally required by law to have an up-to-date Hazard Analysis Critical Control Point (HACCP) system and must be able to demonstrate its effectiveness in order to obtain a Good Manufacturing Practice Certificate.
A Good Manufacturing Practices (GMP) certificate provides independent verification and certification that the basic manufacturing practices and prerequisites necessary for the implementation of an effective Hazard Analysis Critical Control Point (HACCP) food safety program are being followed.
Many food industry companies have implemented the Good Manufacturing Practice certification scheme for food processing as the foundation upon which they have developed and implemented other quality and food safety management systems, including HACCP, ISO 22000, SQF and ISO 9001.
Good Manufacturing Practices are a set of regulations, codes, and guidelines for the manufacture of:
- Drug substances and drug products in Nigeria
- Medical devices in Nigeria
- In vivo and in vitro diagnostic products in Nigeria
- Foods in Nigeria.
- Good Laboratory Practice
A Good Manufacturing Practices (GMPs) are an essential foundation for the development and implementation of successful HACCP plans. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and food service operations.
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