Analyst Qualification SOP

Analyst Qualification SOP in Pharmaceuticals | Analyst Qualification Guidelines | SOP for Analyst Qualification |

1.0 OBJECTIVE :

To lay down a procedure for training and qualification of the Analysts in Quality Control Department.

2.0 SCOPE :

This procedure is applicable to all analysts (Executive and below), involved in the analysis of Raw materials, packaging materials, Finished Products, and stability samples through Chemical, Instrument and Microbiological techniques in Quality Control Department.

3.0 RESPONSIBILITY :

Analyst
- To Perform assigned tests and calculations on the specially selected samples in accordance with the analytical procedures.
QC Head or his/her designee
- To Provide resources as per the training needs of analysts to ensure Certification requirements are met.
- To Review the certification procedure.
- To Provide the samples to the analyst.
- To Prepare protocol for analyst certification.
QC Head or his/her designee and QA Head or his/her designee
- To Review the training need of the analyst.
- To Supervise and review the analyst certification test results & training document
QA Head
- To Approve analyst’s certification plan.
- To Approve analyst’s certification training document.

4.0 ACCOUNTABILITY:

Quality Control Head

5.0 PROCEDURE :

5.1 After completion of induction training program, the new joiner shall undergo qualification process for all tests/ techniques relevant to that area in which analyst is supposed to work.

5.2 The identified tests will be noted in List of Techniques for Analyst Qualification in Annexure No. 01 by section head and approved by Head QC.

5.3 The qualification of the analyst on relevant analytical techniques shall be carried out using the flow chart provided in Annexure No. 02.

5.4 New analyst shall not start independent analysis without complying with the certification criteria in analytical technique of the relevant area.

5.5 The on-job training shall be imparted to analyst by qualified/trained analyst for a minimum 7 days and the record of on-job training shall be maintained in format of On-Job Training record, Annexure No. 03.

5.6 After successfully completion of on-job training, qualification procedure for the analytical techniques will be started.

5.7 The on-job training and qualification procedure will be completed within 30 days after the completion of training programme.

5.8 Section head shall generate the Analyst Qualification Number (A.Q. No.) for each analyst by following the procedure given below and this number shall be referred in analyst qualification raw data;

AQXXXXYYZZ
- Where
- AQ stands for Analyst qualification,
- XXXX denotes the four digits Employee Code Number
- YY last two digits of the year
- ZZ denotes the serial number (as per number of analytical technique to be qualified)

5.9 Non Complex Analytical Techniques

Non Complex Analytical Techniques are those for which a practical demonstration shall be provided by the trainer.
As part of demonstration of these techniques, the section head or a qualified/trained analyst shall explain the test procedure to the analyst who is under training.

5.10 Complex Analytical Techniques

Complex analytical techniques are those for which the practical training is required.

5.11 Training on analytical techniques shall be carried out under the supervision of the section head or a qualified/trained analyst by using on routine sample and by following the relevant specification, standard test procedure and SOPs.

5.12 A lot of on routine suitable sample shall be provided for the analyst Qualification along with the analytical procedure.

5.13 The analyst shall analyze the sample in accordance with the analytical procedure as per the Annexure No.04.

5.14 Trainer shall ensure that the analyst undergoing qualification performs correct unit operations. In case the analyst found to be not following correct unit operations when performing the analysis, get the test repeated completely or only those steps where the unit operation was not correctly followed and record all details in protocol for Analyst Qualification Annexure No. 05.

5.15 The results of the analysis will be summarized within five working days from the date of sample issue.

5.16 The trainer shall use the checklist as per Annexure No. 06 to verify that the analyst undergoing qualification performs correct unit operations.

5.17 The trainer shall review the results and determine if the analyst is qualified based on acceptance criteria provided in the Annexure No. 04.

5.18 Trainer shall then enter the details of the analytical techniques in which the analyst is qualified in Analyst Qualification Record Annexure No. 07.

5.19 Certificate of analyst qualification shall be initiated by the evaluator and certified by Department Head and Head QA in Annexure No. 08.

5.20 If the analyst is not qualified, then the relevant steps indicated in the flow chart of the Annexure No. 02 shall be followed.

5.21 The Analyst Qualification records of Quality Control shall be maintained in format of Analyst Qualification Skill Matrix, Annexure No. 09.

5.22 Analyst Qualification Skill Matrix shall be updated on quarterly basis or as and when required.

5.23 Analyst Qualification Skill Matrix shall be signed as “Prepared by” by Section head, “Checked by” by Head QC and “Approved by” by Head QA.

5.24 Analyst qualification performed during this quarter period, will be updated in addendum for Analyst Qualification Skill Matrix Annexure No. 10 and addendum for Analyst Qualification Skill Matrix will be kept along with Analyst Qualification Skill Matrix after authorization of QA.

5.25 The details of the same will be updated in Analyst Qualification Skill Matrix in Annexure No. 10 on regular basis during the period of quarter.

5.26 After revision of Analyst Qualification Skill Matrix by incorporating the details of addendum for Analyst Qualification Skill Matrix, the same addendum for Analyst Qualification Skill Matrix will be submitted to QA along with obsolete version of Analyst Qualification Skill Matrix.

5.27 The details of SOP schedule training shall be documented and recorded in individual training records.

5.28 Qualified analyst shall undergo re-qualification for the particular technique, in case of a repeated error and technique which is not performed since more than two months.

5.29 For Re-qualification, a single analysis of routine sample shall be performed with Qualified/ trained analyst.

5.30 Microbiological analysis qualified analyst shall be immediately re-qualified, if is there any major changes in testing procedure or repeated error.

6.0 ABBREVIATIONS:

Abbreviation	Expanded form
SOP	Standard Operating Procedure
No.	Number
QC	Quality Control
QA	Quality Assurance
Dept	Department
No.	Number

7.0 ANNEXURES:

Annex. No.	Title
01	List of Techniques for Analyst Qualification
02	Flow Chart for Analyst Qualification Process
03	On-Job Training record
04	Non-complex & Complex Analytical Techniques for Analyst Qualification
05	Protocol for Analyst Qualification
06	Checklist for Analyst Qualification
07	Analyst Qualification Record
08	Certificate of Analyst Qualification
09	Analyst Qualification Skill Matrix
10	Addendum for Analyst Qualification Skill Matrix