It describes the (Standard Operating procedure) Sop for Sop for Analyst Qualification

 

Sop for Analyst Qualification

I: Purpose and Scope :

• The purpose of this SOP is to lay down a procedure to establish capability of Analyst to perform analysis accurately and perform Microbiological testing.    
• This procedure is applicable for Analyst Qualification in quality control Laboratory

II: Responsibilities:

•  All Microbiologist, Quality control personnel shall be responsible to follow and implement this SOP.

III: Introduction and Procedure:

For Analyst working on Chemical & Instrumental:

After completion of induction training, job specific training on related SOPs and STPs shall be provided to both i.e. trainee analyst and analyst with previous experience.

Analyst with previous analytical experience

• After completion of job specific training, need for qualification of analyst with previous analytical experience shall be evaluated by respective section in-charges or department Head.
• This evaluation shall be based on personnel interaction with the analyst, his analytical expertise and assigned job responsibility
• In either case, whether the analyst is required to be qualified or not, Executive/Section in charge-QC shall endorse his opinion in writing in Annexure I.

Trainee Analyst (No previous analytical experience) :

• Analyst shall be trained for “General Tests & Techniques” (Ex.-Physical test, Chemical tests & general instruments like as Analytical Balance, pH meter KF Apparatus) under supervision of qualified analyst.
• After completion of training on General Tests and Techniques, analyst shall be trained on the required sophisticated instrument/s under supervision of qualified analyst for minimum of 3 month for HPLC and 5 days period for other instruments.
• During this period he/she can assist qualified analyst in preparatory work.
• Once the analyst trained he/she shall be qualified for analysis on sophisticated
• Executive/ Section in charge-QC shall evaluate the analyst for recommendation for Qualification. As per Annexure I.

Analyst shall be formally qualified for carrying out analysis on one or more of the following sophisticated instruments.

• HPLC, UV and for Assay Test.
• KF apparatus –for Water Content.

Sample Allocation :

• Executive QC/Section in charge shall select sample from current Lot/Batch (Finished product/Active Raw Material) which has been recently approved or under analysis.
• The analysis shall be performed as per specified STP for specified test
• No repetition of test shall be allowed to the analysts.
• After completion of analysis, the report along with raw data shall be submitted to Executive/Section in charge- QC
• The samples shall be labeled with following information

Sample for Analyst Qualification
Material/Product Name
Test/s
Instrument /s
Ref. STP No.

• In case of analyst qualification KF apparatus the above labeled sample shall be allocated to analyst to be qualified. In case of analyst qualification on HPLC, UV, and the above labeled sample shall be allocated for analysis to a qualified Analyst and analyst to be qualified.

Recommendation & Certification:

• Executive/Section in charge-QC shall recommend certification of analyst after review of required training and analysis results.
• In case of the results not meeting with the acceptance criteria re-training shall be imparted to the analyst and re-qualification shall be done.
• Head-QC shall review recommendation and issue certificate to the analyst.
• Once analyst is certified he/she shall be eligible for carrying out tests in which he/she is qualified.
• All the analytical data of analyst qualification i.e. chromatograms, raw data sheets, spectra and qualification certificate shall be preserved for future reference.
• A list of certified analyst for analysis on sophisticated Instrument shall be maintained.

For Microbiologist:

• After completion of induction training, job specific training on related SOPs and STPs shall be provided to both, trainee Microbiologist and Microbiologist with previous experience.

Microbiologist with previous experience :

• After completion of job specific training, need for qualification of Microbiologist shall be evaluated by section in-charge.
• This evaluation shall be based on personnel interaction with the Microbiologist, his expertise and assigned job responsibilities.
• In either case, whether the Microbiologist is required to be qualified or not, Executive/ Section in charge-QC shall endorse his opinion in writing.

Trainee Microbiologist (No previous analytical experience) :

• Trainee Microbiologist shall be trained for general procedures required in microbiological testing, viz., operation of equipment & instruments related to microbiology section, general preparatory work, sterilization processes, record maintenance, media preparation, culture maintenance, environment monitoring etc., under supervision of a qualified Microbiologist.
• After completion of training on general procedures microbiologist shall be trained on specialized testing. This shall be done for minimum of 15 days.
• During this period he/she can assist qualified microbiologist in preparatory work.
• Once the Microbiologist is trained he/she shall be qualified for carrying out these tests.
• Executive/Section in charge QC shall evaluate the Microbiologist for Recommendation for Qualification.

Microbiologist shall be formally qualified for carrying out, one or more of the following tests:

Sterile Dosage Forms :

• Gram Staining
• Total Aerobic Viable count;
• Test for specified microorganism (Pathogens Identification);
• Test for Sterility
• Bacterial Endotoxin Test

Sample Allocation :

• Executive /Section in charge QC shall prepare the samples for various test and label the same with following information

Sample for Microbiologist Qualification
Sample Name
Test
Ref. STP No.

 Gram Staining :

Executive/Section in charge QC shall select one Gram (-) bacteria and one Gram (+) bacteria. Code these samples and give to the microbiologist for Gram Staining. The test shall be carried out as per Standard Test procedure of respective material.

Total Aerobic Viable count :

Executive/Section in- charge shall analyze Purified water sample along with new analyst, same sample on same day shall be analyzed by new microbiologist. The test shall be carried out as per Standard Test procedure of respective material.

Test for specified microorganism (Pathogens Identification) :

Executive/Section in charge shall select 1 known microorganism from the pure culture, Code it and give it to microbiologist for testing. The test shall carry out as per Standard Test procedure of respective material.

Test for Sterility :

Executive/Section in charge QC shall prepare three samples, consisting two sterile and one non-sterile sample, Give one sample of approved sterile finished product, one sample of sterile purified water and one sample of non sterile purified water. Code it as Sample A, Sample B and Sample C. Give it to microbiologist for testing. Test shall be carried out as per Standard Test procedure of respective material.

Bacterial Endotoxin Test (BET) :

• Microbiologist for performing BET shall be qualified for Limit test for Endotoxin:
• Microbiologist shall be provided with 2 coded samples of approved Sterile Water for Injections (SWFI) (out of which one samples shall be spiked with endotoxin).
• No repetition of test shall be allowed to the Microbiologists.
• After completion of testing, the report along with data shall be submitted to Executive/Section Head.

Executive/Section in charge- QC shall check :

• Report & Data to ensure that the testing has been performed correctly.
• Variation in results of “Total Aerobic Viable count” reported by both microbiologists shall not be more than 20%.
• “Gram staining” has been identified correctly.
• Microorganisms have been recovered correctly in “Test for specified microorganism”.
• In “Test for sterility” sample has been correctly identified as Sterile or Non sterile.
• In test for BET samples have been correctly identified as passing or failing.

Recommendation & Certification :

• Executive/Section in charge-QC shall recommend certification of Microbiologist after review of required training and testing results.
• In case of the result/s not meeting with the acceptance criteria re-training shall be imparted to the Microbiologist and re-qualification shall be done
• Head-QC shall review recommendation and issue certificate to the Microbiologist.
• Once a Microbiologist is certified he/she shall be eligible for carrying out tests in which he/she is qualified.

Re-qualification

• In case of amendment in the responsibility of analyst.
• In case of amendment in the responsibility of Microbiologist.

 

IV: Annexures : 

Annexure No.	Annexure Name
Annexure  I	Analyst Qualification Pre-requisite
Annexure  II	Analyst Qualification form
Annexure  III	Analyst Qualification Certificate
Annexure  IV	List of Certified Analyst
Annexure  V	Microbiologist Qualification Pre-requisite
Annexure  VI	Microbiologist Qualification Form
Annexure  VII	Microbiologist Qualification Certificate

 

 

Annexure: I

Analyst Qualification Pre-requisite

                                                                      

Name of Analyst		Employee Code
Qualification		Date of Joining
Past Experience (Yr)		Review Date

A. Experienced Analyst

1. Job specific training provided?                                                              Yes                 No

2. Training on Good Laboratory practices provided?                               Yes                  No

3. Brief Description of nature experience

4.  Recommended for:                           Qualification                    Certification

 

B. Trainee Analyst
1.  Job specific training provided?	Yes	No
2.  Training on Good Laboratory practices provided?	Yes	No
3. Training on General Test & Techniques required?	Yes	No
4.   Trained for analysis on sophisticated instrument?	Yes	No

 

C. Qualification Required

1. HPLC                                                                   2.  UV Spectrophotometer

3.KF Apparatus                                                        4.  Other

 

D. Reviewed & Recommended by :

Name          :                                                   Designation:               Signature/Date :

 

 

Annexure: II

Analyst Qualification form

                                                                                                                                                                  

                                                                                                                        

Name of Analyst:                                                                       Employee Code:                                        Joining Date :

Date
Instruments	HPLC	UV	KF Apparatus	Other
Test	Assay	Assay	Water Content
Batch No./AR. No.
Approved Analyst  Result
Trainee Analyst Result
Variation			NA
Acceptance Criteria	Variation NMT 1 %	Variation NMT 1 %	—-to—–
Result: Pass/Fails
Recommendation *
Recommended by (Sign)/Date

* Recommendation-Certification (c) or “RTQ” for re-training & qualification.

 

Annexure – III

Analyst Qualification certificate

 

This is to certify that Mr. /Ms.					E.Code
has undergone training and has successfully completed the Qualification test for Analysis on;
1			2
3			4

He/she is certified as ‘QUALIFIED ANALYST’ for analysis on above Instruments.

 

Issued on

(HEAD QAULITY CONTROL)

 

Annexure IV                      

Name of the Instrument:

Sr. No.	Name of Analyst	Employee code	Certification on

 

Annexure-V

Microbiologist Qualification Pre-Requisite

 

Name of Microbiologist		Employee Code
Qualification		Date of Joining
Past Experience (Years)		Review Date

 

A.            Experienced Microbiologist
1.	Training on General procedures of Microbiology provided?			Yes		No
2.	Job specific training provided?			Yes		No
3.	Brief description of nature of previous experience:
4.	Recommended for:                                 Qualification		Certification

 

B.     Trainee Microbiologist
1.	Training on General procedures of microbiology provided?	Yes		No
2.	Job specific training provided?	Yes		No
3.	Training for testing of specialized tests provided?	Yes		No

 

C.     Qualification Required
	1.      Gram Staining		4.         Test for Sterility
	2.      Total Aerobic Viable count		5.        Bacterial Endotoxin test
	3.      Test for specified organism

 

D.      Reviewed & Recommended by :

Name          :                                       Designation:                                                           Signature/Date :

 

 

Annexure: VI

Microbiologist Qualification Form 

 

Name

E.Code

Joining Date

1. Gram Staining

 

Date	Type	Test Organism given	Result	Inference
	a.    Gram (+)
	b.    Gram (-)
Recommended for Qualification/Retraining.   Reviewed & Recommended by: Name:                                     Sign/Date:

1. Total Viable Aerobic Count in spiked sample:

 

Date	Sample Details	Results (CFU)		Variance (NMT 20%)	Inference
		Approved	New Test
Recommended for Qualification/Retraining.   Reviewed & Recommended by: Name:                                     Sign/Date:

1. Test for Specified Organism

 

Name of Given Micro-organism:

Date	Test Steps	Test procedure	Observation/s	Inference
	Secondary Test
	Confirmatory Test
	Identified organism
Recommended for Qualification/Retraining.   Reviewed & Recommended by: Name:                                   Sign/Date:

 

 

  

1. Test for Sterility

Date	Sample	Observation/Result	Intended Result	Inference
	A
	B
	C
Recommended for Qualification/Retraining.   Reviewed & Recommended by: Name:                                    Sign/Date:

 

1. Bacterial Endotoxin Test

 

Date	Samples	Observation	Test Sample (EU/ml)	Inference
	SWFI(Approved)
	SWFI(spiked)
Remark:
Recommended for Qualification/Retraining.   Reviewed & Recommended by: Name:                                    Sign/Date:

 

 

Annexure: VII

Microbiologist Qualification Certificate     

This is to certify that Mr. /Ms.

 

E.Code			has undergone training and has successfully
completed the Qualification test to carry out the following test/s;
1				2
3				4
5
He/she is certified as ‘QUALIFIED MICROBIOLOGIST’ to carry out the above specialized tests.

 

Issued on

(HEAD QUALITY CONTROL)