WHAT IS GMP CERTIFICATION NIGERIA?
GMP Certification in Nigeria stands for Good Manufacturing Practice. It is a system for making sure that products are always produced and controlled according to excellent requirements. It is designed to decrease the dangers in any pharmaceutical manufacturing that can’t be removed via testing the very last product.
How does GMP certification in Nigeria ensure desirable production practices?
The important goal of GMP certification of an employer is that such an agency complies with the stringent requirements and practices for manufacturing pharmaceutical products.
What are the procedures accompanied by GMP certification in Nigeria?
The following high-level steps are concerned with getting a GMP certification:
- Application: A properly laid out and complete application, along with all relevant documentation, needs to be submitted to IAS alongside the processing rate. This should be submitted by means of a senior professional of the corporation who has adequate know-how of your manufacturing centres and strategies accompanied by their organization to avoid any discrepancies in a while.
- In-residence inspection: The utility is then assessed for completeness, compliance necessities and the chance of certification primarily based on all available records provided by way of you. Documentation on the corporation is then gathered. This allows to similarly entire the software earlier than an on-website evaluation is executed.
- On-website Assessment: An on-site visit is then finished by using the IAS auditors of your facility in order to examine the gadget in the area and verify the applicant’s claims of conformance with GMP requirements. The auditors are assisted with the aid of your Quality Assurance employees.
- Inspection file: A comprehensive inspection record with distinctive observations is ready for submission to IAS in conjunction with the certification prices.
- Evaluation of deficiencies: The deficiencies stated on your web page throughout the on-site visit are evaluated. It is likewise determined whether you have thoroughly addressed these issues or not.
- Documentation of deficiencies: A deficiency meeting is arranged with the applicant to review the document and to ensure that all problems have been effectively addressed by using them. It is likewise ensured that your machine is ready for certification.
- Documents submission: Once all of the deficiencies are general, a pre-certification inspection report is sent, which summarizes all observations and deficiencies and how they have been addressed. The pre-certification report is likewise dispatched to the patron with a request for motion as needed. IAS will then send you a final certificate based on your response to this document or will let you recognize that an inspection wishes to be executed once more as consistent with the IAS widespread system.
- Certification: The certificates are then issued to the company upon a successful finishing touch of all requirements.
When does GMP certification in Nigeria expire?
GMP Certification requires re-inspection at regular periods, which vary depending on danger assessment through IAS. The periodicity for re-certification inspections is between six months and years. A facility can be inspected as quickly as corrective movements are implemented for any non-conformance troubles.
Is GMP certification in Nigeria required?
GMP certification is now turning into an enterprise trend for lots of industries, both nationally and internationally. All pharmaceutical producers ought to now comply with the requirements of Annex eleven of the EU Falsified Medicines Directive. Annexe 11 of the EU FMD basically specifies a listing of necessities for certification, inspection and Good Manufacturing Practices (GMP) as a part of regulatory requirements to ensure that drugs are secure and effective. GMP is likewise obligatory in many other nations across the globe, with Aus Australia, Japan, Brazil and many others.
What are the advantages of GMP certification in Nigeria?
The most important benefits of getting a GMP certification are:
- Ensures compliance with international standards and legal guidelines/guidelines.
- Enhances purchaser self-assurance for your product.
- Helps to win commercial enterprise from new clients not only locally but also the world over.
- It can be used as an advertising device to distinguish your product from that of the competition.
- Helps to create an emblem image in the market.
GMP certification is complemented by using satisfactory control gadget certifications like ISO 9001, ISO 13485 and so forth. That is mandatory for positive industries internationally. However, it ought to be stated that these requirements check overall performance, but it’s miles the GMP certification (which comes below Annex eleven) which guarantees compliance with global necessities.
Is GMP certification in Nigeria pricey?
IAS is one of the maximum cost-powerful solution carriers in the industry, recognized for low costs and transparent invoicing. The charge structure at IAS is extremely consumer-friendly without any hidden prices. The price relies upon different factors like – a variety of synthetic batches at your facility, the production capacity, etc.
Can IAS offer GMP certification in Nigeria much less than six months?
IAS has streamlined its GMP certification method to rapidly track requests from clients where viable. We can offer GMP certification within six months of filing the software.
Why Factecert for GMP Certification in Nigeria?
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