SOP for Control of Record of Analysis in Quality Control : Pharmaceutical Guidelines

SOP for Control of Record of Analysis in Quality Control

Standard operating procedure of analysis record in Quality Control.

1.0 OBJECTIVE

To lay down the procedure for control of the record of analysis.

2.0 SCOPE

This SOP is applicable for control of the record of analysis in Quality Control.

3.0 RESPONSIBILITY

Officer / Executive - Quality Control

4.0 ACCOUNTABILITY

Manager - Quality Control

5.0 PROCEDURE

5.1 All Raw data sheets used for record of analysis shall be pre-numbered.
5.2 The numbers of raw data sheet shall have six characters, all numeric. Out of six characters, the first two characters shall denote identification number for the Raw data sheet for which it will be used (finished product/ raw material/ packaging material etc.)
5.3 The remaining four characters shall be a continuous number, starting from 0001 in each calendar year. A typical example of unique number shall be 030001.
5.4 A record other than packing material regarding the issuance of raw data sheet shall be maintained in the respective register for the samples received.
5.5 All raw data sheet shall be in bound book form (having 100 sheets in each book) having a counterpart bearing the same unique number of the Raw data sheet. The record of the issuance of the bound book shall be maintained in a register.
5.6 A book of 100 raw data sheets (Record of analysis) shall be issued to QC supervisor and record for the same shall be maintained. After consumption of the issued book, the counterpart of the old book shall be retrieved and a new book of 100 sheets shall be issued.
5.7 The counterpart of the raw data sheet along with the details duly filled in, shall be retained as such in the book. These books having counterpart shall be retained for a period of 5 years.
5.8 Additional Raw data sheet can be issued to an analyst after specifying the reason for the requirement in the form and authorization by Quality Control Manager.
5.9 The original void raw data sheet if any shall be filed along with the record of analysis with duly authorized form.
5.10 Reconciliation of raw data sheet shall be done at the end of each calendar year. All Unused green sheets shall be destroyed by tearing.
5.11 Control No of raw data sheet must be printed in the footer and should be as follows.
5.12 QC/AA-BB/XX-YY
QC Quality control
AA Identification number of raw data sheet
BB Revision No of the raw data sheet
XX Year of preparation/revision
YY Month of revision

5.13 When any new green sheet will introduce the code number should be represented as follows
‘QC’ will denote quality control
‘AA’ New code number should be given to that particular raw data sheet and maintain it in the annexure which is a live document, with approval and authorization of QC and QA manager respectively.
‘BB’ shall be written as ‘00’ because no revision has been taken place.
‘XX’ shall be written as last two numerics of representative year of preparation or of revision of raw data sheet.
‘YY’ shall be written as ‘00’ for the first time of introduction of the raw data sheet.
Related: SOP for Planning for Analysis and Reporting of Results

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.3 QA - Quality Assurance
6.6 QC - Quality Control





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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