GMP module 06 - Good Laboratory Practice
Outcome of the Module:
Testing laboratories provide a vital function in the provision of accurate and reliable test results. Their customers rely upon these results to make important decisions, particularly in the areas of patient health and consumer protection. Good laboratory practice ensures the safety and suitability of materials, samples and products.
On completion of this module, you should be able to:
- Recognize what comprises a laboratory quality manual.
- Relate the safety requirements of the QC laboratory to day-to-day work practices.
- Distinguish between the different types of laboratory documents.
- Stale the rules for record keeping and data recording.
- Recognize the key features of test methods and specifications.
GLP generally refers to a system of management controls for laboratories and research organizations to ensure the consistency and reliability of results as outlined in the Organization for Economic Co-operation and Development (OECD) Principles of GLP and national regulations.
GLP applies to non-clinical studies conducted for the assessment of the safety of chemicals to man, animals and the environment. According to 21 CFR 58:
” … Nonclinical laboratory study [(GLP)] means in vivo or in vitro experiments in which test articles are studied prospectively In test systems under laboratory conditions to determine their safety. The term does not include studies utilizing human subjects or clinical studies or field trials in animals. The term does not include basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics of a test article.”
Part I: The Lab Quality System
It is well-documented that working within a documented quality systems framework will provide more consistency in laboratory processes, which will in turn improve the laboratory efficiency through error minimization.
Think of the consequential problems if, through a laboratory error, a batch is rejected when it is actually satisfactory: the company will lose the income that would have been generated from that batch. Even worse would be the situation where QC incorrectly passed a defective batch this may have critical consequences for the company, through harm to patients, recall of the batch, and loss of confidence in the company by the regulators and the public. Rather than simply being an overhead, the QC laboratory is often the last chance to catch a problem before it becomes much bigger.
The QC laboratory must have o quality system in place. The primary objective of the quality system is to assure the accuracy and precision of laboratory results so that they will be Reliable, Interpretable, Repeatable and Defensible.
This module is based upon the guidance within GMP rules and ISO 17025 – General requirements for the competence of testing and calibration laboratories. ISO 17025 can be used by laboratories as a standard to develop and establish a quality system, and for the assessment by their clients or by third parties. The standard is also being used as a criterion for laboratory accreditation, but is not industry specific and compliance with this standard is not o regulatory imperative.
A combination of GMP rules and ISO 17025 requirements provide a complete set of requirements for a regulated pharmaceutical QC laboratory. However, in the pharmaceutical industry generally laboratory are audited and licensed according to the GMP rules themselves. ISO 17025 is more of an optional requirement.
Part II: Basic Safety Practices
Laboratory personnel sample and test all chemicals that pass through the factory, and as such may be exposed to potential hazards.
It’s vital that all chemicals, and particularly potent materials, are handled according to the MSDS and sampled according to the specific sampling procedures for that material. This often means wearing masks, gloves, and in some cases respirators, as well as sampling in a biological hazards safety cabinet.
An essential part of induction for new laboratory employees is familiarization with laboratory safety rules and requirements: in particular, the handling of corrosive substances, the wearing of protective garments, eye protection, and familiarity with the MSDS.
Many laboratories include particular safely requirements relating to an instrument or a test method within the test method document itself. Before commencing any test, the analyst should be familiar with these safely requirements.
There are quite a few hazards in a laboratory, including, but certainly not limited to, the following:Unprotected use of solvents
- Equipment not being stored correctly
- Chemical exposure or spillage
- Broken or exploding gloss
- Untidy physical environment
- Repetitive strain injuries
Part III: Laboratory Documents
Testing records and laboratory document retention procedures ore required because it is a GMP and legal requirement to retain critical documents for prescribed periods. there are many instances where access to historical documents and records beyond the minimum GMP requirement are needed, for example, with product safety investigations, pharmacovigilance reviews, complaint investigation, and legal enquiries. Any SOP or policy should reflect these business needs as well.
The laboratory documents are designed to ensure there is linkage between the standard procedures and test methods (what is required to do) and the laboratory records (what was actually done). This forms the laboratory records quality system.
Laboratory test methods are critical documents that must be exactly followed when performing a test, and are controlled and approved by management. Test methods usually have the following features:
- ‘Written By:” (test expert)
- “Reviewed By:” (laboratory supervisor)
- “Approved By:” (laboratory manager)
- Unique document number and revision code
- Document scope
- Safety notices
- Instruments and materials
- Sytem suitability limits
- Details of the method steps
- How the results are calculated and recorded
Part IV: Record Keeping
Accurate and traceable laboratory records are vital for a number of reasons. They are used to verify that all test results are accurate, and that no errors have been made in calculating results at the lime of batch release. They are used in the event of a complaint or marketplace problem to confirm that the batch under review was tested reliably. In some cases, this information may also be used legally to verify that the laboratory did not make any errors.
Laboratory records are also often audited by regulatory agencies during GMP inspections or investigations. The official must be satisfied that the right results have been calculated and entered. Without a fully traceable record, this is very difficult to prove.
Many laboratories use computer systems to process test data because, if properly validated and secure, this approach can reduce potential errors in calculations. The computer system cannot safeguard against incorrectly entered data, so traceable records including initial observations are also needed.
Part V: Test Methods and Specifications
Pharmacopoeial monographs provide general conditions for performing test methods. Pharmacopoeial methods are considered robust that is, they have been validated in multiple laboratories, but each laboratory will use unique instrumentation, different analysts and probably prepare samples differently.
This means that pharmacopoeial methods must be verified as suitable for each laboratory in which they are used: this is a form of validation. Port of the verification and transfer to the laboratory involves preparing a specific test method that is validated and used for initial analyst training. It is expected that companies publish specific in-house methods.
Test methods and specifications are at the heart of any well-run laboratory.
Well-written test methods drive good analytical techniques, effective training, analyst competency, method validations, and minimize laboratory errors. Well-written specifications provide unambiguous acceptance criteria for each test, and demonstrate that test results are in compliance with product registration details and pharmacopoeial monographs.
Maintaining these methods as current is one of the key success factors for any regulated laboratory.
Conclusion:
This module has introduced the basic concepts and requirements of pharmaceutical quality control.
The pharmaceutical QC laboratory operates within o regulatory framework. its day-to-day operations are governed and outlined in a quality manual, which, among other things, will list all the SOPs necessary for the smooth running of the laboratory.
As with any responsible workplace, the QC laboratory has certain solely and housekeeping requirements by which personnel must abide. MSDSs are instrumental for helping personnel work with chemicals. A very basic rule to follow is if personnel are in doubt as to how to proceed, they should be encouraged to ask a supervisor for assistance.
Maintaining documentation is pivotal for success, not only tor SOPs but also for documents such as laboratory records and notebooks. GMP rules and common sense govern how records should be completed (e.g. recording all calculations, conducting second checks, never using whiteout or erasers). Documents and records also provide available and traceable evidence to interested parties such as regulators that the laboratory has conducted testing within a quality system framework.
Online Quiz:
- Number of questions: 10
- No time limit
- Allow you save and finish at a later date
- Allow you to go back and change your answer
- Attempting each question is mandatory
- Pass mark at and above 70%
- Print results and certificates