- Objective:To lay down a procedure for Qualification of Analyst working in the QC laboratory
- Scope:This Standard Operating Procedure is applicable to Quality Control Department followed at Name of Pharmaceutical company with location.
- Responsibility:QC personnel shall be responsible to follow the procedure as per SOP.
- Accountability:Department Head & QA Head shall be accountable for implementation of this SOP.
- Abbreviations and Definitions
- SOP : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
- Department Head of Chemical & Instrument section shall allot approved samples with codification to analyst for any of the tests i.e. Assay of active raw materials, Specific Optical Rotation of Raw Materials, Dissolution Test for Finished Product, Assay of Finished Product.
- Before allotment of sample to analyst for qualification, Department Head shall ensure that all necessary training has been given to analyst.
- Coding of sample shall be done as per AQ/XX/YY.
- ,where AQ stands for Analyst Qualification,
- XX stands for serial no. for coded samples. e.g. 01 shall be for first sample.
- YY stands for last two digits of the year. e.g. 16 shall be for 2016.
- Sample codification shall be maintained in Annexure.
- The analyst shall analyze the sample as per respective procedure and record the data in the report as per Annexure.
- The analysis shall be carried out in triplicate. Mean Result and % RSD shall be calculated.
- Mean Result shall be compared with original result.% Variation between this result and original result for different tests shall be as per Table-I. Record shall be maintained as per Annexure.
Table – I
|% RSD between three cumulative results||% Variation between Mean Result and Original Result|
|1||Assay of Active Raw Material||1 %||1 %|
|2||Specific Optical Rotation||1 %||1 %|
|3||Dissolution||5 %||5 %|
|4||Assay of Finished Product||1 %||1 %|
- If the results found out of acceptance criteria, the immediate supervisor shall conduct investigation for the cause and if it is due to analytical error, then the analyst shall be retrained for the respective SOPs/Procedure and shall be again qualified.
- List of Qualified Analyst shall be maintained as per Annexure.
- Certificate of Qualified Analyst shall be prepared as per Annexure.
- The analyst qualification shall be carried out once in a year.
- Forms and Records (Annexures)
- List of Allotted Sample for Analyst Qualification-Annexure-I
- Analytical Test Data Sheet for Analyst Qualification-Annexure-II
- Summary Sheet of Analyst Qualification
- List of Qualified Analysts
- Certificate of Qualified Analyst
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Quality Control
Reason for Revision
|List of Allotted Sample for Analyst Qualification|
|Sr. No.||Date||Analyst Name||Product||Batch No.||Code Assigned||Remarks|
Worksheet For Analyst Qualification
Name of the Employee: Designation:
Date of Analysis
Sample Name: Code No.:
Test Name: Test write up:
Analyzed By/Date Checked By/Date
Summary Sheet of Analyst Qualification
Name of Analyst
% RSD Analysed By:
% Variation of result of sample assigned for analyst qualification w.r.t. original result:
(Mean Result of sample assigned – Original Result) X 100 =
Verified By: Approved By:
List of Qualified Analysts
|Sr. No.||Analyst||Qualified on||Next Qualification Due on||Remarks|
CERTIFICATE OF QUALIFIED ANALYST
Pharmaceutical Company Name
Quality Control Department
This is to certify that Mr./Miss ___________ has been qualified for one year to carry out analysis in Quality Control Laboratory in order to reproduce accurate results.
His next qualification due date is _________________
|Prepared By / Date||Checked By / Date||Approved By / Date|
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube