SOP for Numbering system for analytical document to be used for regulatory submission
Objective:- To lay down a procedure for numbering system for analytical document to be used for regulatory submission.
Scope: This SOP is applicable for numbering system for analytical document to be used for regulatory submission in quality control laboratory.
Responsibility: Chemist or above of QC Laboratory.
Accountability: Head – Quality Control.
Procedure: Quality Control personnel shall prepare the analytical document for long term, intermediate and accelerated stability study data, summarized protocols for stability studies of exhibit batches and commercial batches, Exhibit Batches Constitution Study Protocol and Reports for Stability Study, and Exhibit Batch Constitution and Compatibility Study Protocol and Report.
Summary Sheet for Stability Study Data:
Stability Summary Sheet for Long term Stability Study data shall be prepared.
Stability Summary Sheet for Intermediate Stability Study data shall be prepared.
Stability Summary Sheet for Accelerated Study data shall be prepared.
Summarized Protocol for Stability Study of Exhibit Batches:
Summarized Protocol shall be prepared as per Annexure and document number shall consist of 17 alphanumeric characters e.g. PRT/ESS/XXXXXX-ZZ
First three characters ‘PRT’ denote protocol.
Second characters ‘/’ slash is separator.
Third three characters ‘ESS’ shall denote exhibit batches stability studies.
Fourth character ‘/’ slash is separator.
Fifth six characters ‘XXXXXX’ denote product code.
Six characters shall denote dash (-).
Seventh two characters ‘ZZ’ denote version number e.g. ‘00’ for new version.
Summarized Protocol for Stability Study of Commercial Batches:
Summarized protocol shall be prepared as per Annexure and document number shall consist of 17 alphanumeric characters e.g. PRT/CSS/XXXXXX-ZZ.
First three characters and second character defined above.
Third three characters ‘CSS’ shall denote commercial batches stability studies.
Fourth character, fifth six characters, sixth character and seventh two characters defined above..
Exhibit Batch Constitution and Compatibility Study Protocol:
Exhibit Batch Constitution and Compatibility Study Protocol shall prepare as per Annexure and document number for protocol shall consist 20 alphanumeric characters e.g. PRT/CCS/XXXXXX/YY–ZZ
First three characters ‘PRT’ denote protocol
Second character ‘/’ slash is separator
Third three characters ‘CCS’ denote constitution and compatibility study
Fourth character ‘/’ slash is separator.
Fifth six characters ‘XXXXXX’ denote product code
Sixth character ‘/’ slash is separator.
Seventh two characters ‘YY’ denote protocol number
Eighth character ‘–‘dash is separator.
Ninth two characters ‘ZZ’ denote version number.
Exhibit Batch Constitution Study Protocol of Stability Study:
Document number for Exhibit Batch Constitution Study Protocol of Stability Study shall consist of 20 alphanumeric characters e.g. PRT/CSS/XXXXXX/YY-ZZ
First & second, character defined above.
Third character ‘CSS’ denoted constitution study of stability
Fourth, fifth, six, seventh, eighth & ninth character defined above.
Report for Exhibit batch Constitution and Compatibility Study:
Exhibit batch Constitution and Compatibility Study report shall be prepared as per annexure.
First character ‘RPT’ denotes Report.
Second character is slash ‘/’ for separation.
Third character ‘CCS’ denotes constitution and compatibility study.
Fifth, six, seventh, eighth and ninth character defined above.
Analytical data shall be recorded in the supplementary.
Report for Exhibit batch Constitution Study for Stability Study:
Report for Exhibit batch Constitution Study for Stability Study shall be prepared as per annexure and document number shall consist of 20 alphanumeric characters e.g. RPT/CSS/XXXXXX/YY -ZZ
First three characters ‘RPT’ denote report.
Second two characters ‘CSS’ denote constitution study for stability sample
Third, Fourth, fifth six, seventh, eighth and ninth character same as above.
List of Annexure
- Summary Sheet for Long Term Stability Study Data
- Summary Sheet for Intermediate Stability Study Data
- Summary Sheet for Accelerated Stability Study Data
- Summarized Protocol for Stability Studies of Exhibit Batches
- Summarized Protocol for Stability Studies of commercial Batches
- Exhibit Batch Constitution and Compatibility Study Protocol
- Exhibit Batch Constitution Study Protocol of Stability Study
- Report for Exhibit Batch Constitution and Compatibility Study
- Report for Exhibit Batch Constitution Study of Stability Study