AP004
Analyst
Qualification
Standard
Operating Procedure
(Analytical
Sciences)
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| Analyst Qualification |
Version No.:
Effective
Date:
Review Date:
Supersedes:
Author(s):
Technical Approver
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Authorized By
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Name
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Designation
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Head of
Department
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Director /
DI
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QA
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Signature
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Date
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1.
Purpose
The purpose of this
SOP is to describe the procedure of analyst qualification program for
conducting an analysis using an approved method.
2.
Scope
This procedure
covers analysts at Analytical sciences laboratory, Location Name, Analytical
test houses for out sourced analysis, consultants and temporary employees
involved in current GLP regulated activities.
3.
Abbreviations
/ Definitions
GLP – good
Laboratory Practices
Method
Certification is only required for quantitative (assay, degradation, etc.) and
semi-quantitative (dissolution, limit tests, etc.) methods used for stability,
and regular batches analysis and for raw material release testing. Training for most methods is covered in
Section 4.1, training for dissolution methods in Section 4.2 and Section 4.3
covers compendial test methods. Section 4.4
states the criteria for a qualified trainer.
4.1 General Test Methods
4.1.1 A minimum of a reference to the results and
conclusion of method training should be documented on the Method Training
Record, Appendix I. The Method Training
Record form will be placed in the scientist training file. The signatures of both the scientist and
trainer indicate that the scientist has read and understood the method and has
performed it acceptably. It should be recorded with the data in a laboratory
notebook. A signature confirming, date
and LNB reference confirming training should be entered into the Method
Training Record.
4.1.2 A scientist must be trained by a qualified trainer as defined in
their training records. The scientist
and trainer will each prepare six separate weighings/preparations on the same
or different days (no more than five working days apart). Acceptance Criteria, e.g. % RSD for each set
of data and overall % RSD for both sets, must be established prior to the
beginning of the training. Typically,
the % RSD value should taken from previously completed validations, refer to
the respective validation reports under Method Precision acceptance criteria.
4.1.3 If the scientist fails to meet the acceptance criteria, an
investigation of the trainers and trainees results must be conducted (generally
within five working days, as per SOP AP, Investigation of Atypical and Out of
Trend Results) and documented in the laboratory notebook. As appropriate, depending upon the
conclusions of the investigation, re-training should be conducted.
4.1.4 Once the scientist/analyst and trainer are of the opinion that
scientist understands how the method should be performed, re-testing may be
initiated, if appropriate. In order to
be qualified (after failing to meet the acceptance criteria initially), the
analyst must perform the method acceptably on a different day using six
different weighings/preparations.
4.1.5 If the scientist/analyst still fails to meet the acceptance
criteria, the function manager/designee must evaluate the data and make a
determination, in conjunction with QA, of action to be taken.
4.1.6 If results are in agreement with the established acceptance
criteria and both the scientist/analyst and trainer are of the opinion that the
scientist is capable of independently performing the method, the scientist can
be considered qualified to perform that method.
Alternatively, other acceptance criteria can be used if justified, and
approved by QA.
4.1.7 Re-qualification should be considered if a scientist/analyst or
the trainer has not performed the method within the past 24 months, or if any
major changes to a method have been made.
The analyst may be re-qualified by performing precision and system
suitability (where applicable), refer to the respective validation reports
under the Method Precision acceptance criteria.
LNB references to the re-qualification records should be added to the
Method Training Record form placed in the scientist training file. Where scientists or trainers have been
performing equivalent methods, re-qualification need not be performed, see
Section 4.1.8.
4.1.8 Actual results may be documented
in the analysts training file (Appendix II - Table 1.). The signatures of the scientist and trainer
indicate that the scientist has read and understood the method and has
performed it acceptably the minimum number of times.
4.1.9 If an analytical method is determined by the scientist and
function manager/designee to be similar to a method on which the analyst has
already been trained and subsequently demonstrated proficiency, a written
justification will be prepared by the functional manager/designee. The justification may be placed in the
analysts training file, by means of a memo, or written in a LNB and the
appropriate reference added to the scientist Method Training Record.
4.2 Dissolution Methods
Training on dissolution methods will consist of
successful completion of either chemical calibration (using appropriate USP calibrators)
for Apparatus I/II or by demonstrating the proficiency and skill in conducting
dissolution by already approved method.
To be qualified to use Apparatus I or II, it will be sufficient to
perform calibration on either Apparatus. Results should be documented on the
Method Training Record (Appendix II - Table 2.).
4.3 Compendial
Test Methods
Compendial test methods, for example those used to test
raw materials to an appropriate pharmacopoeia, by virtue of their wide usage
can be considered appropriate for general use.
The procedure outlined in section 4.1 does not apply to non-modified
compendial test methods.
4.4 Method
Experts and Trainers
The person who validates a method is considered the
“expert” and is qualified to train others on that method. Once a person demonstrates proficiency with
the method, that person is able to train others.
5. Responsibilities
It is the
responsibility of the project leader to
ensure that staff are trained in all aspects of this SOP or are deemed to be
competent in its application.
It is the
responsibility of the section head to ensure compliance with this document.
6. References
AP Investigations of Atypical and Out of
Trend Results
QP004 Deviations
QP003 Training
QP004 Deviations
QP003 Training
