SOP for Protocol and Report Numbering System

Standard Operating System (SOP) issuance, controlling, and management of different Protocols and its numbering System in pharmaceuticals for different activities. A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report, and approval.

Protocol Numbering System

1.0   PURPOSE:

    • The purpose of this SOP is to define the procedure for allocating protocol and   report numbering and issuance system.

2.0   SCOPE:

    • This procedure is applicable to:
      • Protocol for other activities
      • Addendum/ Supplement to approved protocol

3.0   REFERENCES:

    • In-house

4.0   RESPONSIBILITY:

    • Quality Assurance Department and Quality control department allot the number of each prot. and maintain the record of prot. numbering and issue working copy of the approved prot. to the user department.
    • Regulatory Affairs or designee, Quality Head & Plant Head review and approved the SOP.
    • Maintenance Dept. shall responsible for preventive maintenance and calibration of equipment and instruments respectively.
    • QA Head shall review & approved process qualification protocol & report for its completeness and correctness with respect to all data and report and to ensure implementation of SOP.

5.0   ABBREVIATIONS USED IN PROTOCOL NUMBERING SYSTEM SOP :

    • DQ : Design Qualification
    • QP : Qualification Protocol
    • URS : User Requirement Specification

6.0   PROCEDURE FOR PROTOCOL AND REPORT NUMBERING:

    • Protocol Numbering :

    • While preparing new prot. inform to QA Head or Designee whom so ever is responsible for allocation of number.
    • QA Officer shall maintain the record for each number allocated inappropriate attachment of this SOP.
    • Numbering system for Prot. and Report for Process qualification, Cleaning validation, Hold time study:
    • The numbering system is distributed in four parts.
      • a) Location Code.
      • b) Activity Code.
      • c) Serial Number/Product name (Product name in case of Process Qualification).
      • d) Version Number.
    • So, the numbering system for any protocol is:
    • Location Code Activity Code/ Serial Number or product name/ Version Number
    • The first character consists of the alphabets “XX”. This represents the name of the Location.
    • The second character is a code of three alphabets and this code shall be decided on the basis of the activity to be performed like PQP for Process Qualification Prot., CLN for Cleaning validation prot.
    • The three digits numeric code after first slash (/) represents the serial number/ product name.
    • For each activity separate serial number shall be maintained, starting from 001.
    • The last two digits numeric code after second slash (/) represents the Version No.
    • This represents the number of versions made for a particular protocol.
    • Version No. shall be maintained, starting from 00.
    • Report Numbering:

    • The report numbering system is distributed in four parts.i.e Location Code Activity Code/ Serial Number or product code (product code in case of process qualification) / Version Number.
    • The first character consists of the alphabets “XX”. This represents the name of the location.
    • The second character is a code of three alphabets and this code shall be decided on the basis of the activity to be performed like PQR for Process Qualification Report.
    • The three digits numeric code after first slash (/) represents the serial no or product name.
    • For each report separate serial no. shall be maintained, starting from 001 and last two digit numeric code after second slash (/) represents the version number.
    • Prot. and report numbering system for activity as such are listed as example is in the table.
Activity First characters Abbreviated form for Activity Code After first slash After second slash Pro. Example Report Example
Location Code Serial Number/Product Name Version Number
Process Qualification XX

 

PQP Product Name Starts from 00

 

XXPQP/Product Name/00 XXPQR/
Product Name/00
Hold Time Study HTP Starts from 00 XXHTP/001/00 XXHTR/001/00
Cleaning Validation CLN

 

XXCLN/001/00

 

XXCLR/001/00

 

  • Numbering system for URS, DQ, FAT and SAT:

    • The numbering system is distributed in four parts.
      • Location Code.
      • Activity Code.
      • Serial Number.
      • Version Number.

                 So, the numbering system for any PTL is:

                 Location Code Activity Code/ Serial Number/ Version Number.

    • The first character consists of the alphabets “XX”. This represents the name of the location.
    • The second character is a code of three alphabets and this code shall be decided on the basis of the activity to be performed like URS for User requirement specification, DQP for Design Qualification, FAT for Factory Acceptance Test, and SAT for Site Acceptance Test.
    • This character shall identify the activity for which prot. shall be prepared.
    • The three digit numeric code after first slash (/) represents the serial No.
    • For each activity separate serial no. shall be maintained, starting from 001.
    • The last two digit numeric code after second slash (/) represents the Version No.
    • This represents the number of versions made for a particular protocol.
    • Version No. shall be maintained, starting from 00. Some examples are given in the table:
Activity First characters Abbreviated form for Activity Code After first slash After second slash Report Example
Location Code Serial Number/ Version Number
User Requirement Specification XX

 

URS Start from 001 Starts from 00

 

XXURS/001/00
Design Qualification DQP XXDQP/001/00
Factory Acceptance Test FAT XXFAT/001/00

 

Site Acceptance Test SAT XXSAT/001/00

 

  • Numbering system for Qualification protocol:

    • The numbering system is distributed in two parts:
      • Activity Code.
      • Serial Number.

                 So, the numbering system for all the qualification prot. is:

                 Activity Code/ Serial Number.

    • The first two characters before slash (/) consist of alphabets “QP”.
    • This represents the abbreviated form of activity.
    • These two characters shall be for all qualification prot.
    • The last numeric after slash (/) represents serial number.
    • This represents the sequential serial number allocated for the qualification prot.

                 Some examples are given in the table:

Activity First two characters After slash Example
Abbreviated form for Activity Code Serial Number
Equipment Qualification QP Starts from 001 QP/001
    • Numbering system for other protocol:

    • The Numbering system for any other activity shall be done as per steps.
    • An abbreviated form of activity shall be decided on the basis of activity being performed.
    • Addendum/Supplement to approval protocol:

    • Any additional activity to be performed apart from the approved prot. shall be addressed as addendum.
    • The number of addendum shall remain same as that of approved proto.
    • The number of addendum shall be suffixed by A,B,C and onward based on no. of addendums.
    • Issuance system:

    • Photocopy of Approved protocols shall be issued to the concerned for collecting the data and shall be treated as a report.
    • Working copy of Approved photocopy shall be authorized from QA Officer whom so ever is responsible for issuance of protocol and report of issuance to be maintained as per 1,2,3&4
    • After completion of collecting data, submit filled copy with necessary attachment to QA Head or Designee.

7.0   ANNEXURES – Protocol Numbering:

Annexure 1:Process Qualification/Cleaning Validation/Hold Time Study/Report Issuance Log 

Sr. No. Date Protocol No. Product Name Issued By/Date Issued to Received By/Date Report No. Remark

Annexure 2:Equipment Qualification Protocol/ URS/ DQ/ FAT/ SAT Protocols Numbering Issuance Log

Sr.

No.

Protocol No. Title Equipment Name/Model Issued By/Date Issued to Received By/Date. Remark

Annexure 3:Equipment Qualification Protocol/ URS/ DQ/ FAT/ SAT Report Issuance Log 

Sr.No. Report No. Title Equipment

Name/Model/Equipment Code No.

Report
Issued By/Date
Report Received By/Date. Remark

Annexure 4:Protocol for Other/Miscellaneous Activities Issuance Log

Date Protocol No. Activity Details Product/
Equipment Name
(B.Size/Code No.)
Protocol
Issued By/Date
Issued to Protocol Received By/date Remark

 

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pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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