GLP (Good Laboratory Practice) | In Pharmaceutical Development

• Facebook
• LinkedIn
• WhatsApp

GLP: Introduction and outcome

GLP regulates pharmaceutical development qualitatively and quantitative. Be it is purchasing materials or process control or intermediate stages or final Active pharmaceuticals GLP play a vital role. That is why I decided to share my skill-based knowledge on this topic.In this article, I will discuss GLP, 21CFR part 58, 21CFR part 11, elements of GLP, QAU and role of GLP in managing sop, stp, protocol, report, validation, reference standards, equipments, calibration and solutions.

GLP (Good Laboratory Practice)

GLP (Good Laboratory Practice) is a quality control system covering the organizational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded and reported.

The Aim of the GLP

• To establish safety culture during pharmaceutical development stage
• To promote pharmaceutical development with high quality test data
• Generate reliable and reproducible data

6 Key Elements of GLP

A laboratory which intends to perform GLP compliant studies should be organized. The following are 6 key elements of GLP organization:

1. Study Director or Head of Department: He or she is overall responsible to control (conduct, interpret, analyze and report the studies result) the studies. He or she should not be overloaded and free to monitor the studies.
2. QA or Quality assurance unit: QA personnel are responsible to audit the Laboratory studies
3. Personnel: They are well educated and skilled to conduct laboratory studies
4. SOP or Standard operating procedure: These are written and approved documents to conduct all laboratory activities
5. STP or standard testing procedure: These are written and approved documents to conduct analysis. It contains details of analytical method of a pharmaceutical.
6. Reference standards: Only the standard characterize using appropriate analytical techniques (like NMR, mass, and FTIR) and calculated potency using an approved chromatographic method should be used for laboratory studies. Standard bottle label should include storage condition, potency, date of opening the bottle, quantity and expiration date.
7. Reagents and solutions: All solid chemicals, liquid chemicals, reagents and solutions must be labelled. Label must contain concertation, date of preparation/ manufacturing, date of opening, quantity and expiry date.
   • Date of preparation
   • Concentration/standard factor
   • Shelf life
   • Date of expiry
   • Prepared by
8. Raw data: Paper notebook should be used to write all laboratory actvities. Data should be reviewed and signed off by laboratory incharge. Nowadays electronic notebooks are also used to write down the raw data.
9. Storage and achieving: There should be a separate room to store all the documents like SOPs, STPs, protocols, reports and raw data. Storage should be done using SOP.
10. Equipments: All equipment used laboratory study and generating data must be in working condition and have history files and SOPs (operational and calibrational). Calibration should be done as per calibration plan or after any break down (as mentioned in the SOP)
11. Protocol and GLP: Activities like validation, tech transfer should be conducted as per defined and pre-approved SOP

GLP and Validation

Validation is one of the most important key requirements of GLP and it includes:

• Equipment hardware validation
• Software validation
• System validation
• Analytical method validation and
• Data validation

GLP and Mini-validation

Mini-validation is performed during pharmaceutical developments to see the authenticity of the developed method under GLP condition. It is performed prior to complete validation or as per regulatory requirement.

DQ, IQ, OQ, PQ and GLP

• DQ (design qualification): DQ must meet the user specification. For example, if the user requires HPLC with binary gradient system, an isocratic HPLC system will not solve the purpose. The necessary and sufficient condition is that there will be no validation if system does not satisfy the user’s requirement.
• IQ (Installation qualification): IQ verifies that the instrument has arrived as purchases and that it has been properly installed
• OQ (Operational qualification): OQ verifies that the instrument functions and performs in the user laboratory as defined in the DQ
• PQ (Performance qualification): PQ includes preventive maintenance an regula test such as system suitability test (SST). For computer system it includes regular data back up, virus checks and change control procedures.

21CFR part 11 and GLP

The 21CFR part 11 (electronic signature and records) deals with data security, integrity, traceability of the Analytical research department, The following are the primary requirements of an Analytical Laboratory as per 21CFR part 11:

• Authorised and traceable access to systems applications
• Use of the Electronic audit trail
• Secure retention of electronic records to instantly reconstruct the analysis
• Implementation of data security, data integrity and confidentiality through limited authorized system access
• Use of secure electronic signatures for closed and open systems
• Mechanism to delete or change records

Note:

• When the study results are submitted to the FDA, archived records must be retained at least for 5 years.
• When the study results are not submitted to the FDA, archived records should be retained at least for 2 years.

Case study: How to make typo correction

The following approach should be adopted while doing the correction

Differences between GLP and GMP

Typical Examples of GLP

The following are some examples of GLP:

• Always wear PPE (personal protective equipment) during the laboratory experiment
• Reas MSDS prior to start the experiment
• Work according to standard operation procedure
• Participate in the refresher training and safety exercises
• Maintain log book for each laboratory activities
• Keep the instrument clean
• Calibrate the instrument prior to schedule date
• Implement internal and external audit system

OOS, OOT, CAPA and GLP

OOS (Out of specification), OOT (Out of trend) and CAPA (corrective and preventive action are governed by GMP guidelines

Advantages of GLP

The following are the advantages of the GLP:

• Safety compliance culture
• Better and safe workplace
• Confidence in result
• Auditable workplace

Advancements in Technology and GLP

Automation and digitalization have revolutionized laboratory processes, enhancing data integrity, and research efficiency. These advancements have enabled laboratories to streamline workflows, reduce human errors, and improve data management.

Laboratories now utilize sophisticated laboratory information management systems (LIMS) and electronic lab notebooks (ELNs) to capture and analyze data more efficiently. These digital tools allow for seamless integration of experimental data, provide enhanced traceability, and enable better collaboration among researchers

Conclusion

I hope this article has helped you understand GLP or Good Laboratory practices and its importance. Now you have the knowledge to implement the GLP culture in the department. pou may also want to check out other articles on my blog, such as calibration UPLC, UV and GC.

If you found this article helpful, then please subscribe to our blog and also write your comment. You can also follow me on Linkedin, Youtube, Facebook and Twitter.

Interview questions on GLP

What do you mean by Good laboratory practice (GLP)?

What is the GLP principle?

What is the code of the GLP?

What is role of QA department as per GLP?

What are the difference between GLP and GMP?

What are the best practices in the laboratory?

What are the different guideline on GLP?

What are the advantages of GLP?

What are the GLP guidelines?

In which case GLP is not applicable?

GLP is not applicable for basic research and development of analytical methods,

What is the difference between validation and qualification?

What is data correction procedure as per GLP?

What is the document archiving policy as per GLP?

What are 5 fundamental points of GLP?

What is data correction as per GLP?

What is the full form of CFR?

References

• A good laboratory practice and current good manufacturing practice, Ludwig Huber, Agilent
• https://safetyculture.com/topics/good-laboratory-practice-glp/

Abbreviations

• GMP: Good manufacturing practice
• GLP: Good laboratory practice
• CFR: Code of federal regulation
• AMV: Analytical method validation
• SOP: Standard operating procedure