What is GMP - Good Manufacturing Practice ?
We all know that microorganisms – bacteria, viruses, protozoans, fungi, etc. are present everywhere in the atmosphere. What if the tablets you are manufacturing or devices you are packaging get contaminated by a few harmful bacterial cells? Even slight error in the concentration of a chemical substance can show a different reaction. What if a few millilitres of a hazardous chemical is poured into that cough syrup? You risk the life of thousands of innocent patients who consume your medicine thinking that it will cure their diseases. Such an erroneous act may compel the government authorities to shut down your manufacturing unit.
To ensure that a scenario like this never occurs, the FDA has enforced a regulation – Good Manufacturing Practice (GMP). The GMP guidelines and principles are legal codification of quality and purity that must be followed right from intake of raw materials to manufacturing, testing and packaging of active pharmaceutical ingredients, medical devices and other products so that the end user gets product in its safest and purest form.
Over hundred countries have provided their own legislation for pharmaceutical, food and biotech companies to comply with GMP guidelines and principles. The basic concept and guidelines of them all remain the same.
GMP Regulations in Good Manufacturing Practice
Almost all the regulations are centred around cleanliness, sanitation, efficiency of equipments, complaint handling, record-keeping and personnel qualifications. Since these guidelines are pretty flexible, it’s helpful for business owners and managers to understand the requirements in their own way and implement them effectively.
The equipments and utensils used should be made of appropriate materials and design to prevent corrosion, dirt or any external chemical agent from altering the composition of ingredients used to manufacture a product.
The employees performing various tasks must have appropriate educational qualification and training. They should wear proper protective gear like hand gloves and apron to prevent contamination and hazards. Forbid them to consume food, drink, tobacco, cigarette smoking within the manufacturing premises.
3- Building and Facilities
Building that houses the manufacturing unit should be of suitable design and size to accommodate all the equipments. Floors and ceilings should regularly be cleaned. Proper sanitation, ventilation and lighting are very important for sanitary as well as staff.
4- Raw Materials
The three most important things to be considered about raw materials are – quality, storage and treatment. Make sure that the raw materials you purchase are of standard quality. Store and treat them properly to avoid contamination, heat, cold and moisture. Label them and take a small sample to test it for purity.
5- Manufacturing Process
Ensure that the process you use is proven to produce a pharmaceutical product of high quality. It should be fully controlled and clearly defined. Any change in the process must be evaluated. Each employee should be handed a process manual written in clear and unambiguous language.
Keep the records and results of sample tests for every batch so that the complete history of the batch, right from the raw materials to distribution, can be traced whenever required.
Label is the statement of identity for any product. It should clearly mention the name of product, ingredients, batch number, manufacturing and expiry dates, direction for use and warnings.
The Pharmaceutical Inspection Cooperation Scheme (PICS) and Pharmaceutical Inspection Convention work together to inspect whether or not the pharmaceutical companies comply with the GMP requirements. If your compliance is poor and many deficiencies are noted, your manufacturing unit has to be re-audited.
Auditing is done by an experienced auditor having a science degree or working experience in pharmaceutical manufacturing. Their responsibility is to identify the weaknesses where the firm needs to improve, complete the audit report and audit checklist. If a member firm is found to be poor in GMP compliance, it has to pass through a second audit.
Simply put, GMP is not an instruction manual on how to manufacture pharmaceutical products. It’s a series of principles to ensure an effective and quality manufacturing process.