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Numbering System for Qualification Documents, Protocols and Reports

  • Objective To lay down a procedure for assigning of number for qualification documents, protocols and reports.
  • Scope This Standard Operating Procedure is applicable for assigning of number for various qualification documents, protocols (validation protocols, various study protocols like stability studies, etc.) and the reports prepared. It also gives the numbering procedure for Site Master File(s) and Validation Master Plan(s).
  • Responsibility
    • All concerned HODs shall be responsible for implementing this SOP while numbering qualification documents, protocols and the reports.
    • Executive, QA shall be responsible for assigning numbers to qualification documents, protocols and their reports.
    • Head, QA shall be responsible for compliance of this SOP.
  • Abbreviations and Definitions
  • URS :  User Requirement Specifications
  • Qualification Documents:Qualification Documents contain studies, which establish confidence that the process equipment and ancillary systems are capable of consistently operating within established limits and tolerances.
  • DQ: Design Qualification
  • IQ:Installation Qualification
  • OQ : Operational Qualification
  • PQ: Performance Qualification
  • HVAC : Heating Ventilation and Air Conditioning
  • Validation : The documentation act of demonstrating that any procedure,
  • Process, equipment, material, activity or system will consistently lead to the expected results.
  • Validation Protocols: A document with pre-determined approved study plan stating How the validation will be conducted and also enlists the acceptance criteria. It will specify who will conduct the various tasks.
  • Validation Reports : A document that summarizes the results of acceptance testing and presents a conclusion that all requirements of the validation protocol have been addressed.
  • Procedure
    • Numbering of Qualification Documents
      • Numbering of qualification documents/validation protocols shall be done as per the following procedure:
      • Q/Type of Document–Equipment Number or System Number–XX/RN
      • The first character shall be ‘Q’ for Qualification.
      • The second character shall be a ‘/’ (slash).
      • The third and fourth characters shall denote the type of qualification document e.g. IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) or any other document as per Annexure – 1 “List of Codes for Different Qualification Documents and Validation Protocols”.
      • The five character shall be a ‘–’ (dash).
      • The next characters will be Equipment Id. number of a particular department (e.g. EQ/PR/001 is the first equipment of Production).
      • The next character shall be a ‘–’ (dash).
      • The next two characters shall be ‘XX’ depicting the revision number of the Qualification Document. These two characters shall be ‘00’ for new equipment and shall be ‘01’ if the equipment is re-qualified for any reasons.
      • The next character shall be a ‘/’ (slash).
      • The next two characters shall be ‘RN’ where ‘R’ denotes report and ‘N’ is the number of times a particular study is carried out completely for the particular ‘Parent Qualification Document’. The report numbering shall not be done for addendum/addenda and the studies related to particular addendum/addenda shall be part of the respective addendum/addenda itself.
      • E.g. First report of Performance Qualification document of equipment installed at production department shall be Q/PQ-EQ/PR/001–00/R1 and similarly second report shall be Q/PQ-EQ/PR/001–00/R2.
  • Numbering of Validation Documents
    • The report numbering of validation documents shall be as follows:
    • PS/Type of Validation/Department XXX-YY
    • The first character shall be ‘P’ for Protocol.
    • The second character shall be a ‘/’ (slash).
    • The next two characters shall be the type of validation document as per the form tilted “List of Codes for Different Qualification Documents and Validation Protocols” (Annexure –1) e.g. PV for Process Validation.
    • The name of the department responsible for the preparation of the document shall be given by two characters as per Annexure –2 “List of Department Names and Codes”.
    • The next three characters shall represent serial numbers of document in ‘XXX’ format starting from 001 to 999 for each type of validation protocol.
    • The next character shall be a ‘-’ (dash).
    • The next two characters ‘YY’ shall represent the revision number (if any). These two characters shall be ‘00’ for new process or method and shall be ‘01’ if the same process or method is re-validated for any reasons.
  • Numbering of Report for Validation Document:
  • The numbering of report for Validation Document shall be exactly same as discussed for the parent document with the only difference being the first character. The first character ‘P’ which stands for Protocol shall be replaced by ‘R’, which denotes Report.
  • The report numbering for first Process Validation Protocol for production (P/PV/PR001–00) shall be R/PV/PR001–00.
  • The report number indicates the number of times the partial or re-validation has been conducted for the same equipment / process on the same validation document with a particular revision and addendum number.
  • Numbering of Miscellaneous Documents
  • Site Master File
  • The numbering of Site Master File shall be as follows: SMF/XX-RN
  • First three characters ‘SMF’ are abbreviation of Site Master File.
  • The next character shall be a ‘/’ (slash).
  • The next two characters ‘XX’ shall be code of Department/Section at a particular site e.g. we can have more than one production blocks dedicated for production of entirely different ranges of products.
  • The next character shall be a ‘-’ (dash).
  • The next two characters ‘RN’ shall be revision number.
  • Validation Master Plan
  • The numbering of Validation Master Plan shall be as follows:
  • VMP/XX-RN
  • Pantoprazole Sodium Sesquihydrate (drugsformulations.com)

  • First three characters ‘VMP’ are abbreviation of Master Validation Plan.
  • The next character shall be a ‘/’ (slash).
  • The next two characters ‘XX’ shall be code of department/Section at a particular site e.g.  we can have more than one production blocks dedicated for production of entirely different ranges of products.
  • The next character shall be a ‘-’ (dash).
  • The next two characters ‘RN’ shall be revision number.
  • Cleaning validation protocols
  • The numbering of cleaning validation protocols shall be as follows P/CV/XXX-XX
  • P represents Protocol
  • second character shall be a slash.
  • Third and 4th characters shall be CV respectively representing cleaning validation.
  • 5th character shall be a slash.
  • 6th , 7th and 8th character shall be numbers from 001 to 999 representing the serial number of cleaning validation protocols.
  • 9th character shall be a dash.
  • 10th & 11th character shall be numbers representing revision number of a particular protocol.
  • First cleaning validation protocol  will have numbering as following, P/CV/001-00.
  • Reports for this protocol shall be numbered as following R/CV/001-00 where P is replaced with word R representing report.
  • Control of Protocols and Reports
    • Concerned person(s), who is/are responsible for preparing the validation documents, protocols and reports from various departments, shall be assigning number to documents as per their serial no.
    • The various documents and their reports shall be approved by the responsible departments heads and finally by Head Quality Assurance.
    • Any changes in the validation protocols and documents shall be done through the Change Control.
    • If necessary Master Copies of process validation, Stability study protocol, Analytical method validation, Technology transfer protocol etc. and reports shall be retained with Document cell( Quality Assurance)be stamped as ‘MASTER COPY’ on the front side of each page.
    • If Required, controlled copy shall be issued to concerned department and QA person shall maintained the record.
    • The distribution and retrieval record of documents and reports whose Master copy is retained by Document cell ( Quality Assurance) shall be done as per SOP.
  • Forms and Records
    • List of Codes for Different Qualification Documents and Validation Protocols – Annexure-1
    • List of Departments Names and Codes – Annexure-2
  • Distribution
    • Master Copy – Documentation Cell (Quality Assurance)
    • Controlled Copies – Quality Control, Production, Stores, Engineering, Documentation Cell
  • History
Date Revision Number Reason for Revision
00 New SOP

Annexure-1

List of Codes for Different Qualification Documents and Validation Protocols 

URS User requirement specification
DQ Design Qualification
IQ Installation Qualification
OQ Operational Qualification
PQ Performance Qualification
CV Cleaning Validation
PV Process Validation
AV Analytical Method Validation
RV Re-Validation
RQ Re-qualification

Annexure-2

List of Departments Names and Codes 

PR Production
QA Quality Assurance
QC Quality control
ER Engineering
WH warehouse

 

Omeprazole 40 mg (drugsformulations.com)

 

About Pharmaceutical Guidanace

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

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