CGMP Certification

GMP certification is a method of verifying that a manufacturer meets the quality standards set by the FDA. It is for this reason, a search has been made on whether Ghanaian businesses have had their products tested for GMP compliance.

GMP Certification for Pharmaceutical, Cosmetics and Medical Device Companies in Ghana

For companies that engage in all these three business lines including pharmaceuticals, food supplements and medical devices, you need to meet requirements set out by the Food and Drugs Authority as well as those for pharmaceuticals.

GMP Vs CGMP Certification

Before looking into that, it is important to understand the difference between GMP and CGMP.

GMP

GMP stands for good manufacturing practices and these practices involve controlling and monitoring factors of a product’s production such as raw material handling, cleaning procedures, pest management, employee training among others to ensure that safe products are produced. It provides assurance that the products are safe for consumers.

CGMP

CGMP stands for current good manufacturing practices and according to FDA (Food and Drug Administration), it is intended for drugs, food, medical devices, cosmetics, or biologics. The FDA regulates these products under different production systems such as 21 CFR 211 for New Drug Products; 21 CFR 210 and 211 for Biologics; 21 CFR 110, 111, 112 for Medical devices and 21 CFR parts 114-126 for Cosmetics.

CGMP or GMP Certification Cost

The certification cost depends on the package/plan selected by a company. The cost mainly differs in terms of products tested and package chose. Some tests are compulsory while others are optional, the cost of GMP certification for Ghanaian businesses will be determined by that.

The initial cost covers a one-year validity period and it is usually paid annually to renew the certification. The costs also differ based on whether you go for a local or international certification company.

Role of IAS in GMP Certification in Ghana

IAS has been in the forefront of certification companies in Ghana. The company is entrusted with very many tasks that are aimed at improving the business environment. IAS offers competitive prices for GMP certification and other related services such as ISO certification among others.

GMP Certification Services Offered by IAS

1. Food Safety Audit
2. HACCP
3. Technical File Assessment
4. Product Recall Management
5. Audit Preparation
6. Clean room
7. GLP/GCP Training
8. Documentation Validation
9. Pre-Registration Audit
10. Regulatory Consulting & Import/Export Assistance
11. Food Safety & Quality Assurance Management System
12. Software Training and Food Safety System Consultation
13. Product Testing & Quality Analysis Services
14. Laboratory Services
15. SOP/Procedure Review Service
16. Facility Audit & Sanitation Assessment Services ( FDA s EN ISO 21728 )

Benefits of GMP Certification in Ghana

A company that has been registered with an internationally recognised body such as IAS is likely to benefit from a lot of things. One can get access to international markets because the products will be safe for consumers in other countries. In addition, it gives a company a competitive advantage over its competitors since customers are able to make informed choices from companies whose GMP certification have been verified.

GMP Certification in Ghana

The process of GMP certification in Ghana is very straightforward and can be done within reasonable time. The steps are standardized but may differ depending on the company you are applying for it from.  It involves five main procedures including vendor selection, pre-site audit, on-site audit, final audit and registration.

The Vendor selection process involves identifying a company that has the experience to provide GMP certification services. The pre-site audit is meant to determine whether the facility complies with GMP rules. It also provides an opportunity for making any operational changes in order to make sure your business operates within the required standards. On-site GMP certification audits are done to physically check the facility and all equipment used.  It involves checking of each aspect of production process including documentation, staff qualification, training services among others. The final audit is meant to ensure that the company has met all the requirements set out by an internationally recognised body such as IAS.

GMP Certification Process in Ghana

The process involves the following: –

• Vendor Selection
• Pre-Site Audit
• On Site Audit
• Final audit and Registration

GMP Certification Requirements for Drugs and Pharmaceuticals Companies in Ghana

Key GMP requirements for pharmaceutical companies include:  

• You must have a quality system that allows you to operate within the parameters of good manufacturing practices.
• You must be able to produce batch records for each product manufactured.
• There should be systems in place that tracks the movement of raw materials and other related components during production process.
• Production staffs must keep a record of tests they run on products and this information should be stored in a file that is easily accessible when needed.

GMP Certification Requirements for Food Supplements

To get food supplement GMP certification in Ghana, you need to meet the following requirements: –

• You must have a quality system that allows you to operate within the parameters of good manufacturing practices.
• There should be systems in place that tracks the movement of raw materials during production process.
• Production staffs must keep a record of tests they run on products and this information should be stored in a file that is easily accessible when needed.

GMP Certification for Cosmetics

In the case of cosmetics, you need to meet GMP requirements as stipulated by The Food and Drugs Authority. In addition, cosmetic products must not contain certain ingredients as stated in the Ghana Standard Codes of Practice and Cosmetics.

GMP Certification for Medical Devices in Ghana

Medical devices have their own set of requirements when it comes to GMP certification in Ghana . You need to make sure that all products and ingredients used during their manufacture comply with the Ghana Standard Codes of Practice.

Additionally, there should be a quality system in place that allows you to operate within the parameters of good manufacturing practices. There should be systems that track the movement of materials as well as staffs who keep record of tests they run. In addition, all medical device production staffs must be properly trained and technicians should have adequate knowledge and skills to carry out their roles in the production process.

Other Requirements for Accreditation

In addition to meeting the above requirements, there are other items that you should consider including: –

You should have a long-term strategy to meet all GMP requirements related to production and quality control. This includes having adequate and qualified staff.

You should be able to show records of tests done on products and raw materials used in the production process. These records must meet certain standards as set out by an internationally recognised body such as IAS.

Documentation, equipment qualification and staff training is another aspect that must meet requirements as stated by an internationally recognized body such as IAS.

Contact us

To know more about the CGMP Certification or GMP Certification in Ghana, contact us at enquiry@iascertification.com