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Analytical Instrumentation
By Amjad Ganma Jan 6, 2013 2:58 pm PST
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I. Introduction
In order to ensure the quality and reliability of data produced by a laboratory, it is necessary to use a systematic method of
qualifying and calibrating the instruments in a way that is appropriate for the type of instrument and which takes the type of
use into consideration. Because reliable data is a key component of GMP, it is covered throughout global regulations and
guidelines.
II. Major Regulatory Guidelines
Code of Federal Regulations Title 21 Part 211 Section 160 Subpart I: Laboratory Controls
The calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an
established written program containing specific directions, schedules, limits for accuracy and precision, and provisions
for remedial action in the event accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and
recording devices not meeting established specifications shall not be used. [43 FR 45077, Sept. 29, 1978, as amended
at 73 FR 51932, Sept. 8, 2008]
Read full guidance.
The FDA is very clear and concise in this section. The expectation is simple: instruments used for GMP testing must be
calibrated on a regular schedule, following a specific procedure, using written acceptance criteria and providing instructions for
what when the results do not meet the specifications. Instruments are not to be used for GMP testing if the calibration testing
does not meet specifications. Although this is generally accepted and followed, one point that is frequently missed is
specifying what should be done, etc.
B. European Medicines Agency
Eudralex Volume 4, Annex 15
Planning for Validation
2. All validation activities should be planned. The key elements of a validation programme should be clearly defined and
documented in a validation master plan (VMP) or equivalent documents.
3. The VMP should be a summary document which is brief, concise and clear.
4. The VMP should contain data on at least the following:
(a) validation policy;
(b) organisational structure of validation activities;
(c) summary of facilities, systems, equipment and processes to be validated;
(d) documentation format: the format to be used for protocols and reports;
(e) planning and scheduling;
(f) change control;
(g) reference to existing documents.
5. In case of large projects, it may be necessary to create separate validation
master plans.
Download the full guidance.
C. International Conference for Harmonisation
ICH Q7: Good Manufacturing Practices for Active Pharmaceutical Ingredients
5.3 Calibration
5.30 Control, weighing, measuring, monitoring and test equipment that is critical for assuring the quality of intermediates
or APIs should be calibrated according to written procedures and an established schedule.
5.31 Equipment calibrations should be performed using standards traceable to certified standards, if existing.
5.32 Records of these calibrations should be maintained.
5.33 The current calibration status of critical equipment should be known and verifiable.
5.34 Instruments that do not meet calibration criteria should not be used.
5.35 Deviations from approved standards of calibration on critical instruments should be investigated to determine if
these could have had an impact on the quality of the intermediate(s) or API(s) manufactured using this equipment since
the last successful calibration.
Download the full guidance.
III. Other Regulatory Guidances
American National Standards Institute
ANSI/NCSL Z540-I-1994,Calibraion laboratories and measuring test equipment-General requirement
International Standards Organization
ISO 10012-1:19929(E),Quality assurance requirements for measuring equipment Part 1:metrological confirmation system for
measuring equipment
Aligning with Current FDA Guidance: To have Analytical Instruments in order and comply with rules and regulations; create
validation support packages (VSP) that aligns with the best practices of instrument qualification and methods validation. Below
Table highlights the validation characteristics and robust protocols. Validation Support Packages (VSP) and Real-time Testing
VSP (RTT VSP) that can help prevent the previously described scenarios in the warning letters. They also align with best
practices and international guidance from organizations such as the Tripartite International Conference on Harmonization
(ICH).
V. Conclusion
Companies are enhancing their compliance functions by adding resources, trying out different organizational structures, and
bolstering a culture of compliance. While companies are struggling with how to measure the effectiveness of these efforts,
they are well aware of the financial and reputational consequences of noncompliance. Companies are also testing different
approaches to their oversight of compliance, though the audit committee tends to take the lead. Moving forward, companies
will need to balance the increasing demands of compliance oversight with the continuing need for adequate attention to
broader strategy issues. This handbook will be a useful tool for the companies to be compliant with the current regulations
and assess drug regulation performance attributed to analytical instrument. By comparing and contrasting the drug regulation
by different regulatory bodies this handbook will help us to draw a conclusion about the components of drug regulatory
systems which constrain or facilitate the effectiveness of drug regulation.