Good manufacturing Practice overview PPT.pptx

GMP ppt preparation tamplet Sample for the biggeniers.

1. GMP - Good Manufacturing Practice

2. Good Manufacturing Practice (GMP) ensures that products are produced and controlled consistently according to quality standards. GMP minimizes the risks involved in any production that cannot be eliminated through testing the final product. GMP covers all aspects of production, including materials, premises, equipment, training, and personal hygiene of staff.

3. Regulations in Good Manufacturing Practice: Almost all the regulations are centered around cleanliness, sanitation, efficiency of equipment's, complaint handling, record-keeping and personnel qualifications. Since these guidelines are flexible, it’s helpful for business owners and managers to understand the requirements in their own way and implement them effectively.

4. 1-  Equipments 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. 2- Personnel 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.  6- Records 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.  7- Labelling 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.  8- Inspection 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. 9- Audits 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.