Good Manufacturing Practices (cGMP) are guidelines established by regulatory agencies to ensure manufactured products such as pharmaceuticals, foods, and chemicals are consistently produced and controlled according to quality standards to protect public health; cGMP covers principles like hygiene, process validation, documentation, training, record-keeping, recalls, and complaint handling for manufacturing facilities and processes. Chemical engineers play a key role in designing and maintaining cGMP-compliant manufacturing facilities and processes for pharmaceutical, biotech, and chemical industries.
Good Manufacturing Practices (cGMP) are guidelines established by regulatory agencies to ensure manufactured products such as pharmaceuticals, foods, and chemicals are consistently produced and controlled according to quality standards to protect public health; cGMP covers principles like hygiene, process validation, documentation, training, record-keeping, recalls, and complaint handling for manufacturing facilities and processes. Chemical engineers play a key role in designing and maintaining cGMP-compliant manufacturing facilities and processes for pharmaceutical, biotech, and chemical industries.
Good Manufacturing Practices (cGMP) are guidelines established by regulatory agencies to ensure manufactured products such as pharmaceuticals, foods, and chemicals are consistently produced and controlled according to quality standards to protect public health; cGMP covers principles like hygiene, process validation, documentation, training, record-keeping, recalls, and complaint handling for manufacturing facilities and processes. Chemical engineers play a key role in designing and maintaining cGMP-compliant manufacturing facilities and processes for pharmaceutical, biotech, and chemical industries.
Good Manufacturing Practices (cGMP) are guidelines established by regulatory agencies to ensure manufactured products such as pharmaceuticals, foods, and chemicals are consistently produced and controlled according to quality standards to protect public health; cGMP covers principles like hygiene, process validation, documentation, training, record-keeping, recalls, and complaint handling for manufacturing facilities and processes. Chemical engineers play a key role in designing and maintaining cGMP-compliant manufacturing facilities and processes for pharmaceutical, biotech, and chemical industries.
The key takeaways are that cGMP refers to guidelines for manufacturing drugs and food products to ensure quality and safety for consumers. It provides minimum requirements around areas like hygiene, environmental control, documentation etc.
The basic principles of cGMP include maintaining hygiene, controlling environmental conditions, clearly defining and validating manufacturing processes, good documentation practices, record keeping, complaint handling and recall systems.
Other good practice systems mentioned are good laboratory practice (GLP), good clinical practice (GCP), good regulatory practice (GRP), good distribution practice (GDP) and good transportation practice (GTP).
CHE102
Current Good Manufacturing Practices
Good Manufacturing Practices (cGMP)
• Refer to guidelines laid down by agencies which
control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products
• These guidelines are laid down with the intention of
providing minimum requirements that a pharmaceutical or a food product manufacturer must meet while manufacturing drugs or food products, which then assures that the products manufactured/produced are of high quality and do not pose any risk to the consumer or public. Good Manufacturing Practices (cGMP) Good Manufacturing Practices (cGMP)
• Good manufacturing practice guidelines
provides guidance for manufacturing, testing, and quality assurance in order to ensure that drug product is safe for human consumption.
• Many countries have legislated that pharmaceutical
and medical device manufacturer must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Good Manufacturing Practices (cGMP)
• Basic concepts of all of these guidelines remain
more or less similar to the ultimate goals of safeguarding the health of patient as well as producing good quality medicine, medical devices or active pharmaceutical products.
• In the U.S.A, a drug may be deemed adulterated
even though it has passed all of the specifications tests and it is found to be manufactured in a facility or condition which violates or do not comply with current good manufacturing guideline. Therefore complying with GMP is a mandatory aspect in pharmaceutical manufacturing. Basic Principles
• Hygiene: Pharmaceutical manufacturing
facility must maintain a clean and hygienic manufacturing area.
• Controlled environmental conditions in order
to prevent cross contamination of drug product from other drug or extraneous particulate matter which may render the drug product unsafe for human consumption. Basic Principles
• Manufacturing processes are clearly defined
and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
• Manufacturing processes are controlled, and
any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary. Basic Principles
• Instructions and procedures are written in
clear and unambiguous language. (Good Documentation Practices) • Operators are trained to carry out and document procedures. • Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented. Basic Principles
• Records of manufacture (including
distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
• The distribution of the drugs minimizes any
risk to their quality.
• A system is available for recalling any batch
of drug from sale or supply. Basic Principles
• Complaints about marketed drugs are
examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence. cGMP in the Philippines – AO 153 cGMP in the Philippines – AO 153
Refer to Administrative Order No. 153, S. 2004
for more details. Other good-practice systems 1. Good laboratory practice (GLP), for laboratories conducting non-clinical studies (toxicology and pharmacology studies in animals); 2. Good clinical practice (GCP), for hospitals and clinicians conducting clinical studies on new drugs in humans; 3. Good regulatory practice (GRP), for the management of regulatory commitments, procedures and documentation. 4. Good Distribution Practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use 5. Good Transportation Practice (GTP) deals with the guidelines for the proper domestic and international transportation of medicinal products for human use. What is the relevence of cGMP in Chemical Engineering? What is the relevence of cGMP in Chemical Engineering?
In The Matter of David B. Jacobs, An Attorney and Counselor at Law Grievance Committee For The Eastern District of New York v. David B. Jacobs, Esq., 44 F.3d 84, 2d Cir. (1994)