SOP on Assigning of Numbers 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 at all formulation sites. 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 :
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:
QS/Type of Document–Equipment Number or System Number–XX/RNAY
The first character shall be ‘Q’ for Qualification.
The second character ‘S’ shall represent name of the site or location of formulation plant where these validation documents shall be implemented.
The third character shall be a ‘/’ (slash).
The fourth and fifth 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 sixth 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) or System Number like HVAC or Water Systems (e.g. SY/EN/001 is the first system of Engineering like HVAC or SY/PR/001 for first system in Production department like Water Systems).
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 at Goa shall be QG/PQ-EQ/PR/001–00/R1 and similarly second report shall be QG/PQ-EQ/PR/001–00/R2.
The report number indicates the number of times the validation has been conducted for the same equipment on the same validation document with a particular revision number.
The last two characters shall be ‘AY’ where A denotes ‘Addendum’, if any, attached to qualification document and Y shall be numeric character starting from 1 to 9, representing the number of times the addenda have been added to the qualification document. These two characters shall be suffixed only if any addendum is added e.g. First report of Performance Qualification document of an equipment installed at production department at Goa shall be and if, first addendum is included after first report then the numbering shall be QG/PQ-EQ/PR/001–00/R1A1 and after second addendum, the numbering shall be QG/PQ-EQ/PR/001–00/R1A2.
If after some pre-decided time interval the Performance Qualification of a particular system is to be carried out again then the numbering shall be as follows: e.g. for HVAC systems.
At zero month : QG/PQ-SY/PR/001–00/R1
At second month : QG/PQ-SY/PR/001–00/R1A1 (When first addendum is included)
At fourth month : QG/PQ-SY/PR/001–00/R1A2 (When second addendum is included)
After six months (Re-qualification) : QG/PQ-SY/PR/001–00/R2
(At pre-decided date, when complete studies including those of addendum are done as a part of complete protocol, the R2 is suffixed at the end)
The addendum shall be added in cases where partial additional validation shall be carried out on the same equipment for any new part installed on the same equipment, depending on the case where additional part is not altering the major functionality of the equipment. Every time the validation Document is revised the numbering of Addendum shall be made part of parent document and shall follow numbering as discussed earlier. On first revision the document shall have following numbering QG/PQ-EQ/PR/001–01/R1 with R1 being the first report for that document.
Note: The addendum/addenda shall be authorized by same persons responsible for signing the parent document or by their designee in absence.
Numbering of Validation Documents
The report numbering of validation documents shall be as follows:
PS/Type of Validation/Department XXX-YYAZ
The first character shall be ‘P’ for Protocol.
The second character ‘S’ shall represent name of the site or location of formulation plant where these validation documents shall be prepared.
The third 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.
The last two characters shall be ‘AZ’ where A denotes ‘Addendum’, if any, attached to validation document and Z shall be numeric character starting from 1 to 9, representing the number of times the addenda have been added to the document. The addendum shall be added in cases where partial additional validation, revalidation shall be carried out on the same process or equipment or for any new part installed on the same process or method, depending on the case where additional part is not altering the major functionality of the process or method. In case of a new validation document or if there is no change in the status of the validation document or protocol, then no addendum number shall be written e.g. if the partial process or method validation/ revalidation is planned with first addendum, after the approval of initial document, the Validation Document shall be numbered as PG/PV/PR001–00A1 with its parent document with no addendum being PG/PV/PR001–00
After any revision, all addenda, if any, appended to the validation documents and protocols shall be merged with the existing protocol to form one complete document and addendum number at the new revision number shall again start at zero. The revision of protocol shall invite complete revalidation work and report number shall again start at zero (0).
Note: The addendum/addenda shall be authorized by same persons responsible for signing the parent document or by their designee in absence.
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 Goa production (PG/PV/PR001–00) shall be RG/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/S/XX-RN
First three characters ‘SMF’ are abbreviation of Site Master File.
The next character shall be a ‘/’ (slash).
Next character ‘S’ shall be site e.g. G-Goa etc.
The next character shall be a ‘/’ (slash).
The next two characters ‘XX’ shall be code of Plant/Block/Section at a particular site e.g. we can have more than one production sites at Goa or 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.
The Site Master File of Baddi one of its Plant (Location Code: 01), at its second revision shall be numbered as SMF/B/01-02.
Validation Master Plan
The numbering of Validation Master Plan shall be as follows:
VMP/S/XX-RN
First three characters ‘VMP’ are abbreviation of Master Validation Plan.
The next character shall be a ‘/’ (slash).
Next character ‘S’ shall be site e.g. G- Goa etc.
The next character shall be a ‘/’ (slash).
The next two characters ‘XX’ shall be code of Plant/Block/Section at a particular site e.g. we can have more than production sites at Goa or 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.
The parent Validation Master Plan for Pharma Plant (Site Code: 01) at Goa formulation plant shall be numbered as VMP/G/01-00.
Cleaning validation protocols
The numbering of cleaning validation protocols shall be as follows
PB/CV/QA XXX-XX
P represents Protocol and G represents Goa location, For other locations first character of the location shall be used, if first character of the two locations are same then second character shall be used.
3rd character shall be a slash.
4th and 5th characters shall be C & V respectively representing cleaning validation.
6th character shall be a slash.
7th and 8th character shall be Q & A which is abbreviation of Quality assurance.
9th, 10th & 11th character shall be numbers from 001 to 999 representing the serial number of cleaning validation protocols.
12th character shall be a dash.
13th & 14th character shall be numbers representing revision number of a particular protocol.
First cleaning validation protocol of Goa site will have numbering as following, PG/CV/QA001-00.
Reports for this protocol shall be numbered as following RG/CV/QA001-00 where P is replaced with word R representing report.
First Addendum protocol for protocol number PB/CV/QA001-00 shall be numbered as PB/CV/QA001-00/A1, where A1 represents addendum 1.
Annexures which are part of new addendum protocol will have word A representing addendum, eg:- 1st annexure of addendum protocol will have numbering as 1A, annexures which doesn’t require any changes shall be used as such from parent protocol.
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 or their designee and finally by Head Quality Assurance or his/ her designee.
Any changes in the validation protocols and documents shall be done through the Change Control (Refer SOP titled “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(s) and QA person shall fill the details.
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 titled “ Document and Data Control.