SOP for ANALYST CERTIFICATION

1.0 Objective:
To provide guideline for confirming that analyst/microbiologist is     capable of performing the analysis accurately and precisely.

2.0  Scope:
 This guidelines are applicable to the analyst & Microbiologist working .The certification is applicable to newly joined analyst, completing satisfactory  trainings.

3.0   Responsibility:
3.1. QA Manager is responsible for conducting internal and external training as per the annual schedule

3.2 Departmental Head shall give training for the analysis of the sample and documentation.

4.0      Procedure:

4.1      PART-I Certification of Chemist and Analyst :

4.1.1    The certification in Instrument section & wet analysis section shall be carried out for the following test(s) as per need.

4.1.1.1  Assay

4.1.1.2  UV/VIS Spectrophotometer

4.1.1.3  Karl Fisher Titrator

4.1.1.4  Thin layer Chromatography

4.1.1.5  Liquid chromatography( HPLC )

4.1.1.6  Gas Chromatogram ( GC)

4.1.1.7  Refractive index

4.1.1.8  Specific optical rotation

4.1.1.9  Limit test like Chloride , Arsenic , Heavy metals, Sulphate, Iron.

4.1.1.10Water analysis

4.1.1.11 Heavy metal analysis (AAS)

4.1.1.12 Others ( Specific test if any)

4.1.2  The Head QC shall identify the analyst and activity in which certification is required.

4.1.3  The Head QC shall identify the samples of known analytical values and code as A,B ,C

4.1.4 The details of the coded samples & code No shall be recorded by Head QC as per annexure-I

4.1.4.1  Date of Certification

4.1.4.2  Name of Analyst

4.1.4.3  Name of Product/sample

4.1.4.4  Sample Code No

4.1.4.5  Sign

4.1.5 The Head Q.C shall brief the analyst regarding the importance of certification , acceptance / re-approval criteria.

4.1.6   The coded samples shall be handed over to the analyst along with the specification & detailed method of analysis and other necessary information.

4.1.7  The Analyst shall perform the analysis on samples coded as A,B,C

4.1.8 The Analyst shall record his/her findings in the worksheet issued to him and handover to Head QC Annexure-I

4.1.9 Head QC shall evaluate the results as per the following criteria

Test	Acceptance Criteria
Assay	RSD of three results NMT 1.0% , Mean value NMT ± 1% of initial value
UV/VIS Spectrophotometer	Shall be comparable with initial value
Karl Fisher Titrator	Shall be comparable with initial value
Thin  layer Chromatography	Shall be comparable with initial value
Liquid chromatography       ( HPLC )	Shall be comparable with initial value
Gas Chromatography      ( GC)	Shall be comparable with initial value
Refractive index	Shall be comparable with initial value
Specific optical rotation	Shall be comparable with initial value
Water analysis	Shall be comparable with initial value
Others ( Specific test if any)	Shall be comparable with initial value

 If the results comply with the acceptance criteria he/she shall be issued certification  for the test (s) Annexure No: II

4.1.11  In case of failure to comply with the acceptance criteria for certification the analyst shall be retrained and then re-evaluated.

4.1.12 In case of two consecutive failure the analyst shall not be considered for recertification for the test (s)

4.1.13 Re-Certification criteria: If analyst is not performing the task/ test for which he/she is certified for a period of more than one year then he/she shall under go re-certification prior to performing the task/test. 

4.2       PART-I Certification of Microbiologist :

4.2.1 The certification of Microbiologist shall be carried out for the following test as applicable

4.2.1.1  Total Aerobic Viable count

4.2.1.2  Test for the presence of Pathogens

4.2.1.3  Assay ( Antibiotic/vitamin)

4.2.1.4 Sterility

4.2.1.5  Bacterial Endotoxin test

4.2.2     The sample for certification of Microbiologist shall be prepared as follows

4.2.2.1   For Total Aerobic Viable Count : Competent microbiologist shall enumerate the count by plating suspension containing  60-100 CFU using any of the available bacterial culture and suspension containing 20-50 CFU using any of the available fungal culture and code as A, B & C separately.

4.2.2.2   For Pathogens: Combination of 4 pathogens  / individual or blank ( without any culture of E.Coli , Salmonella spp, Pseudomonas spp , Staph. Aureus inoculated and Incubated for 48 hours in SCD medium and coded as A,B,&C

4.2.2.3 For Assay ( Antibiotic / Vitamin ) : Sample of Known 

              concentration coded as A,B&C

4.2.2.4 The Head Q.C shall identify 

the sample of known analytical values as

per the procedure describe earlier and code as A,B &C                                                            . 

4.2.2.5   The head Q.C shall brief the microbiologist regarding

the importance of  Certification acceptance , retraining , and re-

evaluation criteria.

4.2.2.6   The coded samples shall be handed over to the
microbiologist along with the specification and detailed method of
analysis and other necessary information.
The microbiologist shall record his/her findings in theworksheet
issued to him  and  handover to Head QC.

4.2.2.7      The acceptance criteria :  Total aerobic viable count: NMT ± 5% variation from the initial value

4.2.2.8      Pathogens:. Accurate detection

4.2.2.9      Microbiological assay: NMT ±5  variation from the initial value

4.2.2.10  Sterility : Accurate detection

4.2.2.11  Bacterial Endotoxin test : Accurate detection

4.2.3   Head QC shall evaluate against the acceptance criteria and record the observation.

4.2.4  The microbiologist shall be certified on the basis of his/her performance, and certification shall be done if the results are within the acceptance criteria.

4.2.5  In case of failure to comply with the acceptance criteria for certification the microbiologist shall be retrained and reevaluated.

4.2.6  In case of two consecutive failure the microbiologist shall be considered for recertification  for the test (s)

       Re-Certification criteria: If microbiologist is not performing the task / test for which he/she is certified for a period of more than one year then he/she shall under go re-certification prior to performing the task/test

         

5.0      Documentation:
Annexure 1 Protocol Analyst           Certification  XXX/FRM/000

Annexure 2   Analyst                         Certification XXX/FRM/000

  
6.0          History of Revision:

Revision No.	Effective Date	Revision details	Reason for revision

ANNEXURE-I PROTOCOL-ANALYST CERTIFICATION Date of Certification                    :________________          Name of Analyst                           :________________         Name of product / sample           :________________           Sample Code No                           :________________         Name of Instrument                      :________________         Instrument ID No.                         :________________        Standard test procedure No         :________________          Name of Test                                :________________

Reagents:

Solution Preparation :

Observations:

Calculations:

Results: Analyst:________________   (Sign & Date)

Evaluation ( To be filled by Head QC) Acceptance Criteria: Analyst results: Remark:____________________________________________________________________________ ___________________________________________________________________________________ Evaluated By: :_______________ (Sign & Date)

SOP No. : XXX/SOP/000            Format No. : XXX/FRM/000-00

                                                                  

                                 

                                      ANNEXURE-II

ANALYST CERTIFICATION

 This is to Certify that _____________is Certified for carrying out analysis of_________________

 HEAD QC:____________

(Sign & Date)

SOP No. : XXX/SOP/000             Format No. : XXX/FRM/000-00