- Differentiate between GMP, GCP, GDP, and GLP
- Explore Good Laboratory Practices as they apply to animal testing labs
- Describe how clinical studies ensure safe, effective, and ethical studies
- Demonstrate the use of clinical studies website to research studies
- Understand Current Good Manufacturing Practices
- Understand what CAPA is and why it is so essential to the FDA and CGMPs.
- Explore different quality documents used in biomanufacturing
- Identify different types of documentation important to a QMS and CGMPs
Good Guidance Practices
Guidance documents (and guidelines) are used to relate the FDA's current regulatory principles and practices for the manufacturing of products. In the previous chapter, you were introduced to some of the good practices that the FDA regulates, along with their CFRs; Current Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practices. In this chapter, we will extend it to Good Documentation Practices as well and discuss some of the more relevant documents to regulatory affairs.
- 5.1: Good Laboratory Practices (GLPs)
- Good Laboratory Practices (GLPs) came about to improve the confidence of drug safety data for non-clinical laboratory studies. These regulations define the quality system used in non-clinical studies and are meant to ensure the integrity and accuracy of study data as well as the framework for the conduct and reporting of nonclinical laboratory studies. These studies are typically performed on animals and focus on the safety testing of drugs that intend to go through human clinical trials.
- 5.2: Good Clinical Practices (GCP)
- Good Clinical Practices (GCPs) apply to the performance of clinical trials of drug safety and efficacy in human subjects. GCPs aim to protect the rights and safety of human subjects and ensure the scientific quality of the studies. Clinical trials are conducted in stages, and each stage must be successful before continuing to the next phase. Good Clinical Practices (GCPs) are a similar set of standards that apply to human subjects of clinical trials and experiments.
- 5.3: Current Good Manufacturing Practices (CGMPs)
- These guidelines for product manufacturing and testing represent a formal quality system that describes the general principles that must be observed during manufacturing. It is the company's responsibility to ensure GMP compliance and to do so efficiently and effectively. To this end, regulations are relatively flexible. It is up to the manufacturer to establish design procedures, processing methods, and testing procedures. This flexibility gives companies room to experiment and innovate.
- 5.4: Good Documentation Practices (GDPs)
- Regardless of the Guidance Practices being followed, they all exhibit the same philosophy of documentation practices, sometimes referred to as Good Documentation Practices (GDPs). The FDA uses the acronym ALCOA (attributable, legible, contemporaneous, original, and accurate) to describe the importance of GDPs. The key to ALCOA is thorough documentation to ensure reproducibility and traceability.