What is GEP in pharma?
Good Engineering Practice (GEP) is defined as combination of standards, specifications, codes, regulatory and industrial guidelines as well as accepted engineering and design methods intended to design, construct, operate, and maintain pharmaceutical and/or biotechnology facilities taking into account not only …
Why is GEP necessary?
GEP underpins activities in the day-to-day operations and forward planning of a pharmaceutical business. The adoption of this methodology leads to a balance of expenditure and activity. In addition, GEP documentation can be leveraged to support verification work.
Why is good engineering practice important?
Good engineering practices are to ensure that the development and/or manufacturing effort consistently generates deliverables that support the requirements for qualification or validation. Good engineering practices are applied to all industries that require engineering.
What is standard engineering practice?
Standard engineering practices means that accepted, peer reviewed sets of criteria are used in designing equipment (i.e. Uniform Building, Electrical, and Fire Codes, recommendations of the American Conference of Governmental Industrial Hygienists, guidelines of the Department of Labor and Industry, etc.).
What is ASTM E2500?
ASTM E2500 is a standard relating to the specification, design and verification of Pharmaceutical and Biotechnological manufacturing systems and equipment. and automation systems that may affect product quality and patient safety.
What is GEP stack height?
According to Environmental Protection Agency (EPA) regulations, GEP stack height is defined to be the tallest of the following: 65 meters (213 feet), as measured from the ground-level elevation at the base of the stack.
What is software engineering practices?
Practice is a broad array of concepts, principles, methods, and tools that you must consider as software is planned and developed.
What are engineering practices?
Engineering practice means any professional service or creative work requiring engineering education, training and experience and the application of special knowledge of the mathematical, physical and engineering sciences to such professional services or creative work as consultation, research investigation, evaluation …
What are some examples of science and engineering practices?
Science and Engineering Practices
- Asking Questions and Defining Problems.
- Developing and Using Models.
- Planning and Carrying Out Investigations.
- Analyzing and Interpreting Data.
- Using Mathematics and Computational Thinking.
- Constructing Explanations and Designing Solutions.
- Engaging in Argument from Evidence.
What are regulations in engineering?
Engineering regulations are government-defined practices to ensure the protection of the public as well as uphold certain ethical standards for professional engineers.
What are some engineering standards?
Commonly Cited Standards
- AASHTO-ACI-AHRI-ASHRAE-ANSI-ASME-ASTM-AWS-DISA-ETSI-
- NACE-NFPA-NEMA-NISO-NIST-NSSN-OSHA-SAE-UL.
- AASHTO (American Association of State Highway & Transportation Officials)
- ACI (American Concrete Institute)
- AHRI (Air-Conditioning, Heating, & Refrigeration Institute)
How many ASTM standards are there?
12,000 ASTM standards
Today, over 12,000 ASTM standards are used around the world to improve product quality, enhance health and safety, strengthen market access and trade, and build consumer confidence.
What does the FDA mean by Good Manufacturing Practice?
FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.
Can a FDA employee depart from a guidance document?
(3) Although guidance documents do not legally bind FDA, they represent the agency’s current thinking. Therefore, FDA employees may depart from guidance documents only with appropriate justification and supervisory concurrence.
How does the FDA come up with regulations?
The FDA takes various steps to develop these rules, including publishing a variety of documents in the Federal Register announcing the FDA’s interest in formulating, amending or repealing a rule, and offering the public the opportunity to comment on the agency’s proposal.
How does the FDA prepare a Level 1 guidance document?
(i) Before FDA prepares a draft of a Level 1 guidance document, FDA can seek or accept early input from individuals or groups outside the agency. For example, FDA can do this by participating in or holding public meetings and workshops. (ii) After FDA prepares a draft of a Level 1 guidance document, FDA will: