What is GMP Contract Manufacturing?
People often ask, what is GMP Contract Manufacturing? Well, Good Manufacturing Practice (GMP) is an ethical system that exists to hold products to an expected standard of quality. It was designed especially with the biotechnology and pharmaceutical vertical in mind to minimize the risks associated with production.
Current Good Manufacturing Practice regulations (cGMP) are enforced by the Food and Drug Administration (FDA) and are widely accepted as the prominent manner to conduct good business.
GMP Contract Manufacturing includes thorough checkpoints for all aspects of production including the building, raw materials, equipment, job training, labeling, and even the personal hygiene of employees. Essentially, any piece of the puzzle that can affect the overall outcome of a product requires written the detail of the correct processes and procedures with mandatory adherence to each step so that the product is consistently manufactured in every instance.
Why is GMP Contract Manufacturing so Important?
Choosing the right manufacturing facility is important to a product company as a mistake or oversight could cost your company hundreds of thousands of dollars in expenses to correct with possible court costs, fines, and risking your product losing valuable time on the market.
Choosing a manufacturer that adheres to current GMP Contract Manufacturing standards may be the solution to avoid such unfavorable outcomes.
The importance is significant to the consumer, as well. A consumer cannot always detect pharmaceutical quality (if it’s safe or effective) through taste, touch, sight or smell. And random testing on small batch samples is not enough alone to ensure product quality. Only through strict and regulated manufacturing conditions can quality be assured. With checks and cross-checks, from the condition of the machinery to the training of employees, can a reliable process and guarantee of a safe and efficient pharmaceutical product become established.
Many people may be wondering what GMP guidelines are or what an inspection checklist may include. We’ve composed an abbreviated list of what you can expect a highly trained FDA official to be looking for as they determine whether a manufacturing site can become GMP certified.
1. Building & Facilities
- Building is the correct size and structure to house materials and has an orderly storage of materials
- Floors, walls and ceilings easily cleanable and clean
- Fixtures, ducts, and pipes do not pose a threat of contamination to products
- Sufficient lighting and ventilation for intended operation
- Proper washroom facilities and sewage systems to address employee needs and facilitate personal cleanliness
- . Is of the correct material, design, and cleanliness
- All surfaces and utensils that come into contact with product are cleaned and sanitized properly
- . Supervisors have the correct training and experience
- Correct garments are worn by employees with direct contact with product
- Consumption of food and drink and tobacco is restricted to appropriate areas
4. Raw Materials
- . Organized and stored properly to avoid contamination or decomposition
- Containers are sealed and elevated off the floor
- Containers are clearly labeled
- Materials are sampled and tested and those not meeting quality standards have a system for removal
- . There are written instructions including formulas and processes for operating systems; equipment used for production is clean and sanitary
- Only approved materials are used and are being sampled for quality control and are cross-checked by secondary measures
- Labels are used and cross-checked and finished products are marked with permanent codes
6. Laboratory Controls
- . Raw materials are being checked for identity, physical and chemical properties, microbial contamination, and hazardous or other unwanted chemical contaminants
- Water supply is tested regularly
- Raw materials and primary packaging materials are documented
- Manufactured batches, finished products, sampling, distribution, shipments and code marks are all documented
- . Identifies ingredients and safety warning on labels
- Name and address of manufacturing company provided
- Any directions for safe use of product
- . Documented kind and severity of complaint or injury, the medical treatment involved, name and location of facility and physician that treated the injury
- . Checking for use of prohibited color additives or other prohibited ingredients
How to choose the right GMP Contract Manufacturing Facility
Now that the importance of using a facility that is compliant with GMP is evident, here is how to do your due diligence incorrectly identifying a GMP Contract Manufacturing facility:
- Check that the facility is registered with the Food and Drug Administration (FDA)
- The facility has been inspected by the FDA and found in compliance with current GMP standards.
- Rated by the FDA