ANALYST VALIDATION PROTOCOL CUM REPORT · 2021. 1. 1. · REPORT No. ANALYST VALIDATION PROTOCOL...

REPORT No.

ANALYST VALIDATION

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PHARMA SCHOLARS MICROBIOLOGY DEPARTMENT

ANALYST VALIDATION

PROTOCOL CUM REPORT

PROTOCOL No.

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TABLE OF CONTENTS

Section No Topics Page No.

1.0 Pre-Approval Signature 03

2.0 Objective 04

3.0 Scope 04

4.0 Responsibilities 04

5.0 Validation methodology 04

6.0 Validation test procedure 05

7.0 Acceptance criteria 06

8.0 Evaluation of test Result 06

9.0 Revalidation Frequency 06

10.0 Conclusion 06

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1.0 Pre - Approval

The Protocol has been prepared, Reviewed and Approved for implementation by the under signed.

Microbiologist

PREPARED BY SIGNATURE DATE

Head Quality Control or Designee

REVIEWED BY SIGNATURE DATE

Head Quality Assurance or Designee

APPROVED BY SIGNATURE DATE

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2.0 OBJECTIVE:

The objective of this protocol is to establish and ensure that the microbiologists working in the

Microbiology Lab of Quality Control Department are capable of performing the Microbial Limit Test as

per the Pharmacopoeia method.

3.0 SCOPE:

This protocol is to qualify the analyst/Trainee for different microbiological testing method as per respective

STP/GTP in microbiology laboratory at ……………..

4.0 RESPONSIBILITIES:

Validation Group consists of following members:

4.1 QA/QC Department Representative

Head QA or designee

Head QC or designee

Executive-Microbiology

4.2 Specific Responsibilities

4.2.1 Microbiologist will write the protocol in consultation with QC/QA Manager.

4.2.2 Head QC or designee will check the protocol for its completeness, accuracy, technical excellence

and applicability.

4.2.3 Head QA or designee will be responsible for final approval of protocol.

4.2.4 Microbiologist will also be responsible for preparing media, the culture dilution as per the current

version of SOP.

5.0 VALIDATION METHODOLOGY:

5.1 The following tests shall be carried out for the validation of Trainee (Microbiologist).

(i) Test for Specified Micro organisms

(ii) Total Viable Aerobic Count

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6.0 VALIDATION TEST PROCEDURE:

Before proceeding for validation following materials are required.

• Cultures.

Escherichia coli

Salmonella sp

Pseudomonas aeruginosa

Staphylococcus aureus

• Sterile Soyabean Casein Digest Medium/Buffered sodium chloride Peptone solution pH 7.0

• MacConkey agar , MacConkey Broth

• Rappaport Vassiliadis Salmonella Enrichment Broth, Xylose – Lysine – Deoxycholate Agar

• Mannitol Salt Agar, Cetrimide Agar

• N,N,N1,N1 tetramethyl-4-phenylenediamine dihydrochloride or Oxidase disc.

• Grams staining kit

6.1 Test for Specified Micro organisms.

6.1.1 Four previously approved raw materials are used as samples and marked as A, B, C and D for

identification.

6.1.2 Deliberately contaminate all the four tube with about 10 – 100 cells of the Microorganism given

below. (Only Sr. Microbiologist knows the sample) which is contaminated. (One sample for one

organism)

- E. coli

- Salmonella sp.

- Staphylococcus aureus

- Pseudomonas aeruginosa

6.1.3 All the four samples are given to Trainee (Microbiologist) for performing the MLT test as per

current version of GTP.

6.1.4 After recommended incubation period the analyst shall observe the results and record the results in

the format as per Annexure I

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6.2 Acceptance Criteria:

6.2.1 The analyst should correctly identify the organism from all the four deliberately contaminated

samples [known to supervisor Microbiology]. For screening of Indicator organism should meet the colony

morphological character on their selective, differential and its specific media plates.

6.3 Total Viable Aerobic Count:

6.3.1 Analysed purified water samples are used as samples and marked as E for identification.

6.4.7 Samples E is given to microbiologist to be qualified for performing the Bioburden test in duplicate

as per current version of GTP.

6.3.3 After recommended incubation period the analyst/Trainee shall observe the results.

6.4.8 The results should be observed by the Analyst/Trainee (Microbiologist) under supervision of supervisor

microbiology and record the results in the format as per Annexure I.

Note: Keep one uninoculated media plate as a negative control and sample E should be perform by the approved

microbiologist along with the trainee microbiologist.

7.0 ACCEPTANCE CRITERIA:

7.1 The total aerobic count should be under specification and the observed results should not more or less

than 10% from previous or parallel analysed samples.

8.0 EVALUATION:

8.1 Compliance to the acceptance criteria will establish the Microbiologist is capable of performing the

limit test.

8.2 Failure to meet the requirement will require the training of the microbiologist and if in any case the

retraining is required the microbiologist will be revalidated to perform the said test.

9.0 SCHEDULE REVALIDATION:

Revalidation shall be carried out in case of

➢ If a new microbiologist joins.

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➢ Each analyst performing the test should re-qualify for every two year.

10.0 CONCLUSION:

Summary report will be prepared, which clearly state the successful achievement of objective of validation.

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ANNEXURE I

1. Total Viable Aerobic Count: Date of Testing: ........................

LAF ID No:…………………

1.1 Sample Preparation

Weight/Volume of Sample taken ........gm/ml and transfer in to........ ml of Buffered sodium chloride

peptone solution /Phosphate buffer/Soyabean casein digest broth Lot No.:.......................

1.2 Test for Bacterial count:

Incubator ID No.: .......................

......ml of sample preparation transfer in to Petri dish of Soyabean casein digest agar media

Lot No.: ........................in Duplicate/Single and Incubate at 30-35°C from ………… to…………(3 days)

Observations:

Plate

No. Cfu Average Dilution factor Average x Dilution (Total Bacterial Count/gm/ml)

Signature & Date: .........................

1.3 Test for Fungal count (Yeast and Molds):

Incubator I.D. No.: ......................

........ml of sample preparation transfer in to Petri dish of Sabouraud dextrose agar media

QUALITY CONTROL DEPARTMENT

Page 8 of 6 DATA SHEET FOR MICROBIOLOGICAL EXAMINATION OF

NON- STERILE PRODUCTS

Name of Material/Product Reference

A.R. No./Inspection Lot. No. Batch No.

Mfg Date Exp. Date

Date of Analysis Date of Release

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Lot No.:............................ in Duplicate/Single and incubate at 20-25°C from.………… to…………(5-7

days)

Observations:

Plate

No. Cfu Average Dilution factor Average x Dilution (Total Fungal Count/gm/ml)

Signature& Date: .........................

1.4 Total viable aerobic count (cfu/gm/ml) = Bacterial count + Fungal count

Total viable aerobic count (cfu/gm/ml) =

Signature& Date: .........................

2. Test for Specified Micro organisms:

2.1 Sample preparation and Preincubation:

Date of Testing: ........................ Incubator I.D. No.: ......................

Weight / Volume of Sample taken: ........................gm/ml and add to Soyabean casein digest broth Lot No.

................ Volume make up to ........ml and incubate at 30-35°C from ................to................ (18-24 hrs.)

Observation:

Growth or Turbidity: Observed/Not observed

Negative Control: Positive/Negative

Signature& Date: .........................

2.2 Test for Escherichia coli:

2.2.1 Selection and Sub culture:

Date of Testing: ………………. Incubator I.D. No.: ......................

1 ml of pre-enriched media transfer to 100 ml of MacConkey broth Lot No.: ................and incubate at 42-

44°C from ................to................ (24-48 hrs.)

Interpretation:

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Acid or Gas Produced/Not Produced


Signature& Date: .........................


Streak a loop full from the MacConkey broth on preincubated plate of MacConkey agar Lot No.:

............................and incubate at 30-35°C from ................to................ (18-72 hrs.)

Interpretation:

Red, non-mucoid colonies of gram negative rods: Present/Absent


Signature& Date: .........................

2.2.2 Confirmation:


Transfer 0.1 ml of pre-enriched media to 5 ml of MacConkey broth Lot No.:………………… and incubate

at 42-44°C from ................to ................(24-48hrs) add ….ml of Kovac’s reagent.

Interpretation:

A red ring of Indole in the upper layer of medium: Present/Absent.


Signature& Date: .........................

2.3 Salmonella species:



0.1 ml volume of Soyabean casein digest medium to 10 ml of Rappaport Vassiliadis Salmonella

enrichment broth Lot No.: .................. and incubate at 30-35°C from ................to................ (18-48hrs.)

Observation:

Colour change or Turbidity: Observed/ Not observed

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Signature& Date: .........................

Date of Testing: ........................

Streak a loop full from the Rappaport Vassiliadis Salmonella enrichment broth on preincubated plate of

Xylose, lysine, deoxycholate agar medium Lot No.:........................and incubate at 30-35°C from

................to................(18-48 hrs.)

Interpretation:

Red colonies with or without black centers: Present/Absent


Signature& Date: .........................

2.4 Pseudomonas aeruginosa

2.4.1 Selection and subculture:


Streak a loop full from the Soyabean casein digest medium on the surface of preincubated plate of

Cetrimide agar Medium Lot No.: ................................and incubate at 30-35°C from ................to................

(18-72 hrs.)

Interpretation:

Generally greenish in reflected light and shows fluoresance under UV light: Present/Absent.


Signature& Date: .........................

2.4.2 Confirmation:

Date of Testing: ........................

Oxidase Disc used, Make.: ........................Lot No.: ........................

Interpretation:

Development of pink color change to purple (Oxidase positive): Present/Absent


Signature& Date: .........................

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2.5 Staphylococcus aureus:


Date of Testing: ........................ Incubator I.D. No.: .......................

Streak a loop full from the enriched culture on the surface of pre incubated plates of Mannitol salt agar Lot

No.: .................…..and incubate at 30-35°C from ................to................ (18-72 hrs)

Interpretation:

Yellow/white colonies surrounded by a yellow zone: Present/Absent


Signature& Date: .........................

2.5.2 Confirmation:


Transfer the suspected colony from Mannitol salt agar in mammalian plasma and incubate at 37°C from

................to................ (24 hrs) and observed the tube for any coagulation at 3 hours of regular interval

upto 24 hrs.

Interpretation:

Coagulation: Observed/Not observed up to 24 hrs.

Signature& Date: .........................

2.6 Candida albicans



10 ml of pre-enriched media transfer to 100 ml of Sabouraud Dextrose broth Lot No.: ................and

incubate at 30-35°C from ................to................ (3-5 days.).

Observation:



Signature& Date: .........................

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2.6.2 Confirmation:


Streak a loop full from the enriched culture on the surface of pre incubated plates of Sabouraud dextrose

agar Lot No.: .................…..and incubate at 30-35°C from ................to................ (24-48 hrs)

Interpretation:

Growth of white colonies: Present/Absent


Signature& Date: .........................

2.7 Clostridium sporogene:

2.7.1 Sample preparation and heat treatment.

Prepare a sample using 1 in 10 dilution of the product and divide into two equal portions not less than 10

ml. Heat one portion at ………for ………minutes and do not heat other portion.



9 ml volume of each Pre-enriched media to 100 ml of Reinforced Medium for Clostridia broth Lot No.:

.................. and incubate at 30-35°C from ................to................ (48 hrs) under anaerobic condition.

Observation:

Color change or Turbidity: Observed/Not observed


Signature& Date: .........................


Streak a loop full from the Reinforced Medium for Clostridia on the surface of preincubated plate of

Columbia agar Medium Lot No.: ................................and incubate at 30-35°C from ................to................

(48-72 hrs) under anaerobic condition.

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Interpretation:

Growth of rods: Present/Absent


Signature& Date: .........................

2.7.3Confirmation:

Date of Testing: ........................

Take suspected colony on the slide and place 2 to 3 drops of 3% H2O2.

Interpretation:

Vigorous bubbling: Observed/ Not observed

Signature& Date: .........................

2.8 Bile tolerant gram negative bacteria:

2.8.1 Test for absence


Weight/Volume of Sample taken: ........................gm/ml and add to ........ml of soyabean casein digest

Medium Lot No. ................ and incubate at 20-25°C from ................to................(2-5 hrs)

Transfer 10 ml of above enriched media to 100 ml of Enterobacteria broth mossel Lot No.: ................and

incubate at 30-35°C from ................to................ (24-48 hrs.)

Interpretation:



Signature& Date: .........................


Streak a loop full from the enriched medium on preincubated plate of Violet red bile glucose Agar Lot No.:

.................. and incubate at 30-35°C from ................to................ (18-24 hrs.)

Interpretation:

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Red colonies surrounded by reddish precipitation zone: Present/Absent


Signature& Date: .........................

2.8.2 Quantitative evaluation

2.8.2.1 Selection and subculture:


Inoculate........ml of EE Broth Medium Lot No. ................ with enriched Lactose broth containing 0.1, 0.01

and 0.001 g/ml of product and incubate at 30-35°C from ................to................ (18-24 hrs)


Streak a loop full from the enriched medium on preincubated plate of Violet red bile glucose Agar Lot

No.:..................and incubate at 30-35°C from ................to................(18-24 hrs.)

Interpretation:

Note the smallest quantity of the product that gives the positive result and largest quantity that gives

negative results and determine from the table.


Observation Table:

Result for Each Quantity of Product Probable No. of Bacteria per g or ml of

Product 0.1 g or 0.1 ml 0.01 g or 0.01 ml 0.001 g or 0.001 ml

+ + + More than 104

+ + - Les than 103 and more than 102

+ - - Les than 102 and more than 10

- - - Less than 10

Probable no. of Bacteria =………………

Signature& Date: .........................

Checked by:…………………….

(Sign/Date)

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1. Total Viable Count: LAF ID No.:……………………...……

Date of Testing: ........................

By Filtration Method

A) Total Aerobic Microbial Count (TAMC) Incubator I.D. No.: ................................

Dilute……..ml of water sample to ……ml sterile purified water. (Diluted Sample)

......ml of diluted sample filtered through membrane filter and place the filter on plate of R2A agar Lot No.:

........................ and Incubate at 30-35°C from ………… to…………

Observations:

Plate No. cfu Volume of Sample Total Aerobic Microbial Count/ml

Signature& Date: ...............................

B) Total Yeast and Mould count (TYMC) Incubator I.D. No.: ............................

........ ml of diluted sample filtered through membrane filter and place the filter on plate of Sabouraud dextrose

agar media Lot No.:......................... and incubate at 20-25°C from ………… to…………

Observations:

Plate No. cfu Volume of Sample Total Yeast and Mould count/ml

Signature& Date: .............................

ANNEXURE 2

DATA SHEET FOR MICROBIOLOGICAL ANALYSIS

Type of Water Reference

Sampling Point Name A.R. Number

Sampling Point ID Date of Analysis

Sampled By Date of Release

REPORT No.

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2. Test for Specified Microorganisms:

2.1 Sample preparation and Preincubation:

Date of Testing: ........................ Incubator I.D. No.: .............................

Volume of Sample filtered: ........................ ml and add the filter to ........ml of Soyabean casein digest broth Lot

No. ................ and incubate at 30-35°C from ................to................ (18-24 hrs.)

Observation:



Signature& Date: .........................

2.2 Test for Escherichia coli:


Date of Testing: ………………. Incubator I.D. No.: ................................

1 ml of pre-enriched media transfer to 100 ml of MacConkey broth Lot No.: ................and incubate at 42-44°C

from ................to................ (24- 48 hrs.)

Interpretation:

Acid or Gas Produced/Not Produced


Signature& Date: ...................................

Date of Testing: ........................ Incubator I.D. No.: .................................

Streak a loop full from the MacConkey broth on preincubated plate of MacConkey agar Lot No.:

............................and incubate at 30-35°C from ................to................ (18-72 hrs.)

Interpretation:

Red, non-mucoid colonies of gram negative rods: Present/Absent


Signature& Date: ..................................

REPORT No.

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2.2.2 Confirmation:

Date of Testing: ........................ Incubator I.D. No.: ...............................

Transfer 0.1 ml of pre-enriched media to 5 ml of MacConkey broth Lot No.:………………… and incubate at 42-

44°C from ................to ................, add ….ml of Kovac’s reagent.

Interpretation:

A red ring of Indole in the upper layer of medium: Present/Absent.


Signature& Date: .................................

2.3 Salmonella species:


Date of Testing: ........................ Incubator I.D. No.: ...............................

0.1 ml volume of Soyabean casein digest medium to 10 ml of Rappaport Vassiliadis Salmonella enrichment broth

Lot No.: .................. and incubate at 30-35°C from ................to................ (18-48hrs.)

Observation:

Colour change or Turbidity: Observed/ Not observed


Signature& Date: ......................................

Date of Testing: ........................

Streak a loop full from the Rappaport Vassiliadis Salmonella enrichment broth on preincubated plate of Xylose,

lysine, deoxycholate agar medium Lot No.:........................and incubate at 30-35°C from

................to................(18-48 hrs.)

Interpretation:

Red colonies with or without black centers: Present/Absent


Signature& Date: ......................................

REPORT No.

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EFFECTIVE DATE



2.4 Pseudomonas aeruginosa


Date of Testing: ........................ Incubator I.D. No.: ……….......................

Streak a loop full from the Soyabean casein digest medium on the surface of preincubated plate of Cetrimide agar

Medium Lot No.: ................................and incubate at 30-35°C from ................to................ (18-72 hrs.)

Interpretation:

Generally greenish in reflected light and shows fluoresance under UV light: Present/Absent.


Signature& Date: ......................................

2.4.3 Confirmation:

Date of Testing: ........................

Oxidase Disc used, Make.: ........................Lot No.: ........................

Interpretation:

Development of pink color change to purple (Oxidase positive): Present/Absent


Signature& Date: ......................................

2.5 Staphylococcus aureus:


Date of Testing: ........................ Incubator I.D. No.: ....................................

Streak a loop full from the enriched culture on the surface of pre incubated plates of Mannitol salt agar Lot No.:

.................…..and incubate at 30-35°C from ................to................ (18-72 hrs)

Interpretation:

Yellow/white colonies surrounded by a yellow zone: Present/Absent


Signature& Date: ......................................

REPORT No.

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2.5.2 Confirmation:

Date of Testing: ........................ Incubator I.D. No.: ...................................

Transfer the suspected colony from Mannitol salt agar in mammalian plasma and incubate at 37°C from

................to................ (24 hrs)

Interpretation:

Coagulation: Observed/Not observed up to 24 hrs.

Signature& Date: ......................................

2.6 Coliforms:

Date of Testing: ........................ Incubator I.D. No.: ...................................

......ml of sample filtered through membrane filter and place the filter on plate of M-Endo agar Lot No.:

........................ and Incubate at 30-35°C from ………… to…………(24 hrs).

Interpretation:

Red colonies with a metallic sheen.: Observed /Not observed


Coliforms (cfu/100ml) =………………

Signature& Date: ......................................

Checked by:……………..……………….

(Sign/Date)

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ANNEXURE 3

SUMMARY DATA SHEET FOR MICROBIAL LIMIT TEST

Prepared By: Checked By:

(Microbiologist) (Head QC)

Name of Sample Batch

No.

A.R. No. Identification No. Limits Observations

Existing Microbiologist New Microbiologist

TBC TFC E. coli Salmo

nella

P.

aerugi

nosa

S.

aureus

-Ve

Contr

ol

TBC TFC E.

coli

Salmonell

a

P.

aeruginosa

S.

aureus

-Ve

Control

REPORT No.

ANALYST VALIDATION


EFFECTIVE DATE



SUMMARY REPORT FOR

ANALYST VALIDATION

Analyst Name:…………………..

PROTOCOL REFERENCE No.

DATE OF REPORTING

REPORT No.

ANALYST VALIDATION


EFFECTIVE DATE



TABLE OF CONTENTS

Section No. Topics Page No.

1. Post Approval Signature

2. Objective

3. Scope

4. Responsibility

5. Acceptance Criteria

6. Findings and Observations

7. Remarks and Conclusion of the Study

REPORT No.

ANALYST VALIDATION


EFFECTIVE DATE



1.0 Post Approval

The Summary report has been prepared, Reviewed and Approved for implementation by the under

signed.

Microbiologist

PREPARED BY SIGNATURE DATE

Head Quality Control or Designee

REVIEWED BY SIGNATURE DATE

Head Quality Assurance or Designee

APPROVED BY SIGNATURE DATE

REPORT No.

ANALYST VALIDATION


EFFECTIVE DATE



2.0 OBJECTIVE

To ensure that the microbiologists working in the Microbiology Lab of Quality Control Department

is capable of performing the Microbial Limit Test of all products as per GTP.

3.0 SCOPE

Applicable to Microbial Limit Test of Product and Purified water.

4.0 RESPONSIBILITY

Trainee :

Trainer :

Head QC :

Head QA :

5.0 ACCEPTANCE CRITERIA

5.1 The analyst should correctly identify the organism from all the four deliberately contaminated

samples [known to supervisor Microbiology]. And the result (Bio burden in purified water)

obtained by both the analyst (Existing Microbiologist & New Microbiologist) should be comparable

with each other and within the specification limit.

6.0 FINDINGS AND OBSERVATIONS

Test Name Product

/Item Name

Batch

No.

Sample

Code

Identification ID Culture added Observation Result

Pathogen

testing And

Total Viable

Count

Purified

Water

LPW-05 AV-

001/13

Sample A E. coli Identify

Pass

Sample B Salmonella Identify

Sample C P. aeruginosa Identify

Sample D S. aureus Identify

Sample F …. cfu/ml

(COA attached)

…..cfu/ml

REPORT No.

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EFFECTIVE DATE



7.0 REMARKS AND CONCLUSION OF THE STUDY:

The results (Total Viable Count) obtained by the trainee and that by the existing microbiologist are

found to be comparable with each other and also well within the specification limit and identified

the organism from all the four deliberately contaminated samples [known to supervisor

Microbiology]. For screening of Indicator organism are meet the colony morphological character on

their selective, differential and its specific media plates. Thus the analysis of the trainee stands

validated and is certified to perform by Water/Raw materials/finished Product analysis

independently as per respective STP/GTP.

ANALYST VALIDATION PROTOCOL CUM REPORT · 2021. 1. 1. · REPORT No. ANALYST VALIDATION PROTOCOL...

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