When it comes to biopharmaceutical research and development, the life sciences industry relies on proven, effective methods that can be adopted and adapted in a variety of contexts. These techniques are “Good Practices” used to produce consistent quality and results.
You have likely seen different acronyms; the following article breaks down the specific focuses of GLP, GCP, GMP, and GDP. In this instance, GDP refers to Good Distribution Practices rather than Good Documentation Practices, which are a systematic procedure of preparing, reviewing, approving, issuing, recording, storing, and archiving documents.
Good Laboratory Practices
Primarily focusing on non-clinical safety studies, such as safety assessments, toxicology studies, and other safety experiments, Good Laboratory Practices (GLPs) ensure the quality, integrity, and reliability of data generated during research and development. Non-clinical does not relate to or involve direct medical services, but instead supports patient care
GLPs encompass how non-clinical safety studies are planned, performed, monitored, recorded, archived, and reported. Documentation requirements emphasize traceability through Standard Operating Procedures (SOPs), study plans, raw data, equipment logs, and study result reports.
For example, GLPs cover safety practices such as wearing clothing and safety glasses to protect against potential splashes, as well as regularly cleaning and calibrating equipment.
Good Clinical Practices
Compared to GLPs, which focus on nonclinical activities, Good Clinical Practices (GCPs) centers on clinical – treating patients through functions like direct diagnosis, testing, treatment, or care.
GCPs typically apply to research and other institutions involved in clinical trials of pharmaceuticals, biologics, and medical devices. GCP guidelines ensure the safety, rights, and well-being of trial participants as well as the reliability of clinical trial results. Various aspects are covered, including trial design, protocol development, resource allocation, data collection, safety reporting, record-keeping, documentation, and beyond.
Since GCP concentrates on patients, procedures include informed consent, ethical reviews, and proper data management to account for the protection of information, regulatory reporting, and more.
Good Manufacturing Practices and GMP Storage
Good Manufacturing Practices (GMPs), which may also be referred to as Current Good Manufacturing Practices (cGMPs), ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use for human or animal consumption. GMP regulations cover the entire manufacturing process, including facility design, equipment qualification, raw material sourcing, production processes, quality control, packaging, labeling, storage, and distribution.
With an emphasis on documentation, GMP requirements involve site master files, SOPs, specifications, analytical methods, manufacturing and labeling batch records, certificates of analysis, and product batch release documentation.
As they are meant for human consumption, GMP storage is also a critical aspect with its own conditions for safety and security. GMP storage conditions can include, but are not limited to:
- Secure with only authorized individuals given access
- Orderly, clean, dry, and temperature-controlled
- Regularly sanitize to ensure the area is pest-free
- Handle separately to prevent contamination
- Adequately and accurately label
- If narcotics are stored, they should be stored in a way that complies with all relevant laws and regulations
Good Distribution Practices
A set of standards for the sourcing, handling, storage, and transportation of medicines for human use and their ingredients, Good Distribution Practices (GDPs) ensure the quality, safety, and security of products throughout the pharmaceutical supply chain. Regulations for documentation are related to the design, development, manufacturing, packaging, and labeling of products.
GDPs are significantly affected by the complexity and risks of the global drug product supply chain, including multiple exchanges, several modes of transportation, and environmental factors. USP provides standards for addressing proper documentation, storage, transportation, and risk mitigation strategies.
With Good Distribution Practices acting as part of the pharmaceutical supply chain, guidelines involve confirming deliveries are valid and accurately labeled, as well as the need to competently and impartially self-inspect.
Global Leader in Compliance
Utilizing relevant Good Practices addresses potential risks, ensures quality standards, aids preparedness, and allows for continuous improvements.
SciSafe makes quality our highest priority for every client. That’s why all of our facilities are fully cGMP-compliant, and we have over 86 Standard Operating Procedures that govern all functions of business, including GMP storage. Additionally, our cutting-edge US sites are ISO 9001 (US and NL facilities) and ISO 20387 (NJ facilities) certified, CAP-BAP accredited, and are GDP-compliant as well.
Contact us today to discuss how we can meet your accreditation and certification expectations.