6/12/2019 Numbering System for Qualification Documents, Protocols and Reports - Pharmaceutical Guidance

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Numbering System for Qualification Documents, Protocols and Reports

Posted By: Pharmaceutical Guidanace on: July 21, 2016 In: QA & QC, Quality Assurance, SOP No Comments

Objective To lay down a procedure for assigning of number for quali cation documents, protocols and reports.

Scope This Standard Operating Procedure is applicable for assigning of number for various quali cation 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 quali cation documents,

protocols and the reports.

Executive, QA shall be responsible for assigning numbers to quali cation documents, protocols and their

reports.

Head, QA shall be responsible for compliance of this SOP.

Abbreviations and De nitions

URS :  User Requirement Speci cations

Quali cation Documents:Quali cation Documents contain studies, which establish con dence that the process

equipment and ancillary systems are capable of consistently operating within established limits and tolerances.

DQ: Design Quali cation

IQ:Installation Quali cation

OQ : Operational Quali cation

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6/12/2019 Numbering System for Qualification Documents, Protocols and Reports - Pharmaceutical Guidance
PQ: Performance Quali cation

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 Quali cation Documents

Numbering of quali cation documents/validation protocols shall be done as per the following procedure:

Q/Type of Document–Equipment Number or System Number–XX/RN

The rst character shall be ‘Q’ for Quali cation.

The second character shall be a ‘/’ (slash).

The third and fourth characters shall denote the type of quali cation document e.g. IQ (Installation
Quali cation), OQ (Operational Quali cation), PQ (Performance Quali cation) or any other document as

per Annexure – 1 “List of Codes for Di erent Quali cation Documents and Validation Protocols”.

The ve character shall be a ‘–’ (dash).

The next characters will be Equipment Id. number of a particular department (e.g. EQ/PR/001 is the rst
equipment of Production).

The next character shall be a ‘–’ (dash).

The next two characters shall be ‘XX’ depicting the revision number of the Quali cation Document. These
two characters shall be ‘00’ for new equipment and shall be ‘01’ if the equipment is re-quali ed 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 Quali cation 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.

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6/12/2019 Numbering System for Qualification Documents, Protocols and Reports - Pharmaceutical Guidance
E.g. First report of Performance Quali cation 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 rst 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
Di erent Quali cation 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 di erence being the rst character. The rst character ‘P’ which stands for Protocol shall be replaced by ‘R’,

which denotes Report.

The report numbering for rst 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.

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6/12/2019 Numbering System for Qualification Documents, Protocols and Reports - Pharmaceutical Guidance
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 di erent 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

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 di erent 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 th
 and 4 characters shall be CV respectively representing cleaning validation.
5th
character shall be a slash.
6th th and 8th
 , 7 character shall be  numbers from 001 to 999 representing the serial number of cleaning validation
protocols.
th
9 character shall be a dash.
th th
10 & 11 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.
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6/12/2019 Numbering System for Qualification Documents, Protocols and Reports - Pharmaceutical Guidance
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 nally
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 Di erent Quali cation 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 Di erent Quali cation Documents and Validation Protocols 
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URS User requirement speci cation

DQ Design Quali cation

IQ Installation Quali cation

OQ Operational Quali cation

PQ Performance Quali cation

CV Cleaning Validation

PV Process Validation

AV Analytical Method Validation

RV Re-Validation

RQ Re-quali cation

Annexure-2

List of Departments Names and Codes 

PR Production

QA Quality Assurance

QC Quality control

ER Engineering
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6/12/2019 Numbering System for Qualification Documents, Protocols and Reports - Pharmaceutical Guidance
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