Manufacturing instructions should clearly and accurately define each manufacturing process step.
Production operators should rely upon following these approved steps of manufacture, not draft instructions. GMP rules do not allow companies to use draft, trial or out-of-date documents in commercial manufacture. The instructions, however, should be based on experience with completing the tasks. If problems arise, the procedures should be revised to reflect exactly what is required.
GLP generally refers to a system of management controls for laboratories and research organizations to ensure the consistency and reliability of results as outlined in the Organization for Economic Co-operation and Development (OECD) Principles of GLP and national regulations.
GLP applies to non-clinical studies conducted for the assessment of the safety of chemicals to man, animals and the environment.
The quality of a pharmaceutical product is defined as one that is pure, correctly identified, effective and safe to use. Customers and patients have an ethical (and legal) right to expect quality pharmaceutical products.
The warehouse plays a pivotal role in manufacturing quality products, as it is responsible for all incoming goods (including labeling and packaging) and for releasing finished products. Therefore, there are GMP rules in place to ensure that materials are handled and stored properly, while appropriate documentation is maintained.
Micro-organisms are a group of organisms that include bacteria, moulds, yeasts, and viruses. They are also very adaptable and can live and multiply in conditions other living things cannot survive in. Micro-organisms are also naturally all around us in the environmental air, on our skin, within row materials and water, on packaging, and on production equipment. Microbiology is the scientific study of microscopic organisms, often called “micro-organisms” or “microbesAlthough micro-organisms are small, the mass of microbial life on earth is 25 times greater than the total mass of animals.
Cross-contamination of product is caused by either:
a. contamination of a batch with a previous batch of the same product
b. contamination with a different product through carryover or proximity of production lines
c. contamination by a foreign starting material usually of the dispensary or in the store
The prevention of the cross-contamination requires A. the proper sealing, separation and storage of raw materials; B. care in management of the dispensary so as to exclude the opening of different lots of containers in close proximity, etc.
Cleaning and sanitation programs are an important part of GMP, as they protect products from environmental contamination and cross-contamination with other materials or product. These programs are also designed to protect us from the effects of hazardous materials.
Cleaning and sanitation are both needed to reduce potential contamination. Contamination could negatively impact the end product if it is present in the manufacturing facility or on production equipment.
Customers of pharmaceutical products expect products that are safe and effective. One of the ways to ensure that products ore safe and effective is by producing finished products that ore correctly identified. Product and labeling mix-ups can result in potentially serious consequences.
As such, GMP rules require that products rules be correctly identified with the correct name, ingredients, strength, and botch information. There must be no unspecified components present
The basic concepts of Quality Assurance (QA), GMP and Quality Control (QC) are interrelated. The sum total of all these entities together comprises the pharmaceutical quality system (PQS). The functions or roles of QA, GMP, and QC are collectively critical to the effective and safe production and control of medicinal products.
Pharmaceutical products must be manufactured according to well-established GMP rules. These GMP rules have been developed over the last 50 years and are based on practical experience and accumulated knowledge in the industry.