Contract Manufacturing
Morison Industries Plc Contract Manufacturing Engagement Procedure
How do I engage in contract manufacturing with Morison Industries Plc?
To engage in Contract manufacturing with Morison Industries PLC, Morison may expect their partners to meet the following conditions before commencing contract manufacturing agreement:
Quality and Regulatory Compliance
- Regulatory Approvals: Possession of necessary licenses and approvals from relevant regulatory bodies.
- Provision of raw materials and packaging materials for the products.
- Documentation and Record-Keeping: Accurate and detailed documentation and record-keeping for the raw materials and packaging supplied for production vis a vis the product released by Morison Industries Plc.
What are the expectations from Morison Industries Plc?
Morison Industries Plc must possess the following conditions:
1. Regulatory Requirements
- NAFDAC Registration: The contract manufacturing facility must be registered with the National Agency for Food and Drug Administration and Control (NAFDAC), ensuring compliance with Good Manufacturing Practices (GMP) and relevant regulations.
- Pharmacists Council of Nigeria (PCN) Registration: The facility must also be registered with the PCN, which oversees the practice of pharmacy and ensures adherence to professional standards.
2. Facility and Equipment Requirements
- GMP Compliance: The facility must adhere to GMP guidelines, maintaining a high level of hygiene, controlling production processes, and documenting all operations meticulously.
- Adequate Equipment: The facility should have suitable equipment for manufacturing and testing pharmaceutical products, ensuring compliance with regulatory requirements
Joint agreement between the contract giver and contract manufacturer
Quality Control and Assurance
- Quality Agreement: A quality agreement should be established between the contract giver and the contract manufacturer, outlining responsibilities and expectations for quality control and assurance.
- Regular Audits: Regular audits should be conducted to ensure compliance with GMP and other regulatory requirements, including audits by NAFDAC and other relevant authorities.
FAQs
Here are some frequently asked questions (FAQs) by companies or individuals applying for contract manufacturing in Morison Industries Plc
What are the requirements for starting a contract manufacturing business in the pharmaceutical industry?
There must be a product that has been duly certified by the regulatory agents.
Do I need a pharmaceutical manufacturing license to start contract manufacturing?
Yes
What are the Good Manufacturing Practice (GMP) requirements for contract manufacturing?
That will be made available by the Contractee having being certified by the necessary regulatory bodies.
How do I ensure compliance with regulatory requirements and industry standards?
By ensuring that the company you are engaging are strictly and duly certified by all necessary regulatory bodies.
Do I need to have a quality control laboratory for contract manufacturing?
No. The company employed to manufacture your products must have a certified quality control laboratory.
How do I handle deviations, investigations, and corrective actions?
By subjecting sample finished products to external laboratory checks.
What are the requirements for auditing and inspecting contract manufacturers?
process check and laboratory check.
How do I select and qualify a contract manufacturer?
By verifying all the relevant approved certified agent certificate.
What are the key elements of a contract manufacturing agreement?
The product to be manufactured must have been certified by necessary regulatory agents and the manufacturing company must complied with all regulatory bodies requirement to manufacture pharmaceutical products.
How do I ensure intellectual property protection in contract manufacturing?
By ensuring a strict compliance to Non – disclosure agreement