Standard Operation Procedure (SOP) of providing training and qualification of analyst for all new appointed personnel, and existing employees who are responsible for sampling & testing of incoming materials, in process samples and finished products.
Analyst Qualification Procedure
1.0 Objective :
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- To lay down a procedure of providing training and qualification of analyst for all new appointed personnel, and existing employees who are responsible for sampling & testing of incoming materials, in process samples and finished products in Quality Control Laboratory.
2.0 Scope :
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- This procedure applicable to all new appointed personnel, existing employees and who are intra transfer from another section for enhancing the skill or fulfill the requirement of any other section in Quality Control department.
3.0 Procedure for Analyst Qualification :
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Training of New Appointed Personnel:
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- Induction training by HR, general training by QA shall be given to new employee as per the procedure described in SOP for Training Management.
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- After completion of induction and general training employee shall be handover to Quality Control.
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- Quality Control Department Head/Designee shall prepare job description of the employee as per SOP.
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- Enclose the controlled copy of JD in Personal Training File after approval.
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- Based on Job description, Training Need Identification of employee shall be prepared as per SOP and Training shall be conducted after QA approval.
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- After completion of trainings new appointed employee shall be recommended for analyst qualification based on Job description.
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Training for existing employee:
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- Qualified trainer shall give scheduled training as per annual training schedule.
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- Qualified trainer shall give On Job Training, Refresher trainings, cGMP Trainings, Class Room Trainings as per the procedure described in SOP.
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Analyst Qualification of New Appointed Personnel:
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- Quality Control shall inform Quality Assurance to collect the sample quantity of finished product required for analyst qualification during packaging stage of batch.
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- Similarly inform sampling person to collect sample quantity of raw material required for analyst qualification during sampling activity.
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- One batch of API or one batch of single drug formulation or multidrug formulation of any product shall be selected. If required, additional batch may be given.
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- Pre-tested sample (Sample of known analytical values & not more than 30days old pre-tested stable product) shall be identified.
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- If pre-approved sample is not available in such case certified standard shall be used for analyst qualification.
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- Use certified values for comparison.
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- The samples will be coded to protect its identity.
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- This code shall be mentioned on the analyst qualification forms.
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- The actual batch numbers are known only to Section Head QC and maintain the record in Annexure-XII.
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The code number will be as follows:
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AQ/YY/XXX
Where,
AQ = Analyst Qualification
YY = Year (“20” for 2020, “21” for 2021 and so on)
XXX = Sequential number i.e. 001, 002 etc.
Example: AQ/20/001, AQ/20/002
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- Sample shall be allotted to analyst along with current specification/STP.
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- Work authorization shall be issued after the completion of qualification and shall be synchronized with job description as per SOP.
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Qualification of Microbiologist :
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- Training of new joining shall be done as per SOP – Training Management.
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- Qualification of microbiologist shall be done as per annexure –X(Analyst Qualification for microbiological testing)
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- Work authorization shall be issued after the completion of qualification and shall be synchronized with job description.
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Evaluation:
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- RSD of all 3 set values and reference value (previous approved batch results) shall be calculated.
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- The acceptance criteria of RSD and for other requirements shall be as mentioned below:
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- The analyst qualification criteria shall be as mentioned in below Table-1.
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- All individual values shall meet the requirements as per specification.
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- Absolute difference of the mean of all 3 set values and reference value shall be calculated (in moisture content/LOD only) and acceptance criteria of RSD of the same shall be as per Table-1
Table-1
| Sr. No | Test | Acceptance Criteria |
| 1 | Assay
|
|
| 2 | Dissolution
(Test shall be performed on 12 Units) |
Dissolution results shall be within specification limit. |
| 3 |
Related Substances :
|
|
| 4 | Moisture(Water) content
|
|
| 5 | FTIR
|
|
| 6 | Melting Point/Range
|
|
| 7 |
Weighing & Pipetting
|
|
| 8 | Viscometer
|
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| 9 | Gas chromatography
|
|
| 10 | Microbial Limit Test | Variation NMT 30% from the results reported by trainer |
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- The Head-QC will review the Analyst Qualification report and qualify the Analyst.
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- If the results are not within the acceptable range, invalidate the data and record in invalid data log.
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- Further training shall be given and the analyst shall be re-qualified.
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Analyst Re- Qualification of Existing Employee:
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- Qualification of regular analyst shall be carried out in the following conditions:
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- Periodic re-qualification of the analyst shall be done at-least once in a two year (+01 month of scheduled month) based on his current job responsibility.
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- Frequent Analyst error observed during OOS investigation.
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- Major changes in analytical techniques.
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- Changes in Job Description.
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- In case if analyst does not meet the acceptance criteria during re-qualification, Quality Control Head/Designee shall evaluate the performance of testing, analysis and then investigate the same.
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- If the root cause of failure is not related to analyst (for example- instrument error/variability) the same set of solutions shall be re-injected after rectification of instrument.
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- If the root cause of failure is due to analyst error, the analyst shall be quarantined and an impact assessment on his/her historical testing results and released batches back to the last successful qualification has to be performed.
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- After the completion of investigation, the analyst shall be explained his/her deficiency/ mistake and trained accordingly. In this case analyst shall be re-qualified before deploying on job.
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- An yearly schedule for analyst qualification shall be prepared in the beginning of each calendar year as per Annexure-XIII.
4.0 Annexure – Analyst Qualification :
Annexure I : Professional Curriculum Vitae
- Personal Information
Name:………………………………………………… Employee code no.:…………………………………………
Date of birth :………………………………………… Male/ Female: ………………………………………………
Qualification :………………………………………… Place of birth: ………………………………………………
Date of joining: …………………………………. International: ………………………………………………
Date of joining in QC dept.: …………………… Marital status :…………………………………………
Resident address: …………………………………………………………………………………………………………
Contact address: ………………………………………………………………………Tel. no. :………………………
Previous Experience : ……………………………………………………………………………………………
Signature: Head QC:
- General Education
|
Date (From……. To……) |
Degree of certificate | School/College/Institute/University | Subject |
Updated by |
- Professional Training Courses
| Date
(From……To…..) |
Title of
Training courses |
Training Organization | Type of certificate
(Attendant or successful) |
Certificate no. | Updated by |
- Work Experience
| Date
(From……To…..) |
Name of team | Work experience | Job title |
Updated by |
Annexure II : Analyst Qualification weighing and pipetting technique
Test: Weighting and Pipetting Technique
| Topic | Pipetting |
Results |
Acceptance criteria | |||
|
Sample 1 |
2 | 3 |
RSD |
|||
|
Weighing and pipetting techniques (1, 2, 5 and 10 ml in triplicate) |
1 ml | RSD: <= 0.5% for values obtained for Set 1 , Set 2 & Set 3 | ||||
| 2 ml | ||||||
| 5 ml | ||||||
| 10 ml | ||||||
Evaluation : The trainee has understood / not understood this phase of the training and qualifies / does not qualify for weighting and pipetting techniques.
Annexure III : Analyst Qualification for Karl Fischer Apparatus
Product/Material Name:
Instrument: Karl Fischer Apparatus
Sample Code:
| Topic | Analyst |
Results |
Acceptance criteria | Analyst Name Sign/Date | ||||
| Set – 1 | 2 | 3 | Mean |
RSD |
||||
| Factor determination | Trainee | RSD ≤ 1.0 % for values obtained for set 1, 2 and 3. | ||||||
| Topic | Analyst | Results | Acceptance criteria | Analyst Name Sign/Date | ||||
|
Set 1 |
2 | 3 | Mean |
RSD |
||||
|
Water Determination in previously analyzed sample |
Trainee | Over all% RSD/Difference of individuals value from the mean
|
||||||
| Previous result | Results: | |||||||
Evaluation: The trainee has understood / not understood this phase of the training and qualifies / does not qualify for the sample analysis by Karl-Fischer Apparatus.
Annexure IV : Analyst Qualification for HPLC
Product/Material Name:
Instrument: HPLC (Assay)
Sample Code :
| Topic | Analyst |
Results |
Acceptance Criteria | Analyst Name Sign/Date | ||||
|
Set 1 |
2 | 3 | Mean |
RSD |
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| Sample analysis
by HPLC |
Trainee | RSD of all 3 set values and reference value should be NMT 2% | ||||||
| Previous
Result |
Result:
(% RSD) |
|||||||
Evaluation : The trainee has understood / not understood this phase of the training and qualifies / does not qualify for the sample analysis of Assay by HPLC
Annexure V : Analyst Qualification Titrimetric Analysis
Product/Material Name:
Test: Titrimetric Analysis
Sample Code:
| Topic | Analyst | Results | Acceptance criteria | Analyst Name Sign/Date | ||||
|
Set 1 |
2 | 3 | Mean |
RSD |
||||
| Sample analysis
by titration |
Trainee | RSD of all 3 set values and previous value should be NMT 2% | ||||||
| Previous
result |
Results:
(% RSD )
|
|||||||
Evaluation : The trainee has understood / not understood this phase of the training and qualifies / does not qualify for the sample analysis by Titration.
Annexure VI : Analyst Qualification for Dissolution apparatus and UV-Vis Spectrophotometer
Product/Material Name:
Instrument: Dissolution Apparatus and UV-VIS Spectrophotometer
Sample Code:
| Topic | Analyst | Results | Acceptance criteria | Analyst Name Sign/Date | ||
| Sample analysis
On Dissolution & UV-VIS Spectrophotometer |
Trainee |
Tablet-1 | Tt-2 | T-3 | Result Should be within specification limit.
Spec Limit: ……………. |
|
| Tablet-4 | T-5 | T-6 | ||||
| Tablet-1 | T-2 | T-3 | ||||
| Tablet-4
|
T-5 | T-6 | ||||
| Results: (Average of 12 units): | ||||||
Evaluation : The trainee has understood / not understood this phase of the training and qualifies / does not qualify for the sample analysis by Dissolution & UV-VIS Spectrophotometer.
Annexure VII : Analyst Qualification for Viscometer
Product/Material Name:
Instrument: Viscometer
Sample Code :
| Topic | Analyst |
Results |
Acceptance criteria | Analyst Name Sign/Date | ||||
|
Set 1 |
2 | 3 | Mean |
RSD |
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| Sample analysis for Viscosity Measurements on Brookfield Viscometer |
Trainee |
RSD of all 3 set values and previous value should be NMT 2% | ||||||
| Previous Result | Results:
(% RSD ) |
|||||||
Evaluation : The trainee has understood / not understood this phase of the training and qualifies / does not qualify for the sample analysis by Viscometer.
Annexure VIII : Analyst Qualification for FTIR
Product/Material Name:
Instrument: FTIR
Sample Code:
| Topic | Analyst |
Results |
Acceptance criteria | Analyst Name Sign/Date | ||
| Set 1 | 2 |
3 |
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| Sample analysis by using FTIR |
Trainee |
Should be comparable with the reference standard/ working standard | ||||
| Result: | ||||||
Evaluation : The trainee has understood / not understood this phase of the training and qualifies / does not qualify for the sample analysis by FTIR.
Annexure IX : Analyst Qualification for Melting Point apparatus
| Topic | Analyst | Results | Acceptance criteria | Analyst Name Sign/Date | |||
| 1 | 2 | 3 | Mean | ||||
| Analysis of melting point of sample by melting point apparatus. | Trainee | Results should meet the specification limit.
Spec Limit: ……………
|
|
||||
Evaluation : The trainee has understood / not understood this phase of the training and qualifies / does not qualify for the sample analysis by Melting Point Apparatus.
Annexure X : Analyst Qualification for microbiological testing
| Topic | Analyst | Results | Limit | Name/sign | ||||
|
Set 1 |
2 | 3 | Mean | RSD | ||||
| Sample analysis by using zone reader | Trainee | Variation: ±5% of previous results.
RSD: ≤ 3% For values obtained for set 1 , 2 and 3 |
||||||
| Previous
result |
Variation: RSD: |
|||||||
Evaluation : The trainee has understood / not understood this phase of the training and qualifies / does not qualify for Microbiological Assays.
Annexure XI : Analyst Qualification for Gas Chromatography
| Topic | Analyst | Results | Acceptance Criteria | Analyst Name Sign/Date | ||||
|
Set 1 |
2 | 3 | Mean |
RSD |
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| Sample analysis
by GC |
Trainee | RSD of all 3 set values and reference value should be NMT
……….
|
||||||
| Previous Result | Result: (% RSD) | |||||||
Evaluation : The trainee has understood / not understood this phase of the training and qualifies / does not qualify for the sample analysis by GC.
Annexure XII : Record of product for analyst Qualification
|
Sr.No. |
Date | Analyst Name | EMP Code | Product /Material Name | Batch /
A.R No. |
Test/
Technique |
Sample Code Allotted | Allotted By |
Remarks |
Annexure XIII : Analyst Qualification Schedule
| Sr. No. | Analyst Name | Emp. Code | Qualification Done On | Re-Qualification Due On | Remarks |
5.0 Glossary
- SOP : Standard Operating Procedure
- QC : Quality Control
- CGMP : Current Good Manufacturing Practices
- GLP : Good Laboratory Practices
- HPLC : High Pressure Liquid Chromatography
- QA : Quality Assurance
- NMT : Not More Than
- Reference Value: A value reported by previously qualified analyst
- GC : Gas chromatography
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