DOCUMENT(S) AND DATA CONTROL PROCEDURE

DOCUMENT(S) AND DATA CONTROL PROCEDURE

PURPOSE

To lay down a procedure for control of documents, documented data and records.

SCOPE

This Standard Operating Procedure is applicable for the control of documents and documented data and records.

REFERENCE(S) & ATTACHMENT(S)

REFERENCE(S)

Chapter-4: Documentation (EudraLex Volume4 GMP medicinal products for Human & Veterinary use.)

A WHO guide to good manufacturing practice (GMP) requirements.

Guidance on Good Data and Record Management Practices- WHO working document QAS/15.624 September 2015.

CROSS REFERENCE DOCUMETS

Preparation, Review, Approval, Issuance & Retrieval of SOPs

Good Documentation Practices

Change Control Management

Handling, Management and Investigation of Deviation

Quality Risk Management (QRM)

Data Integrity and Data Reliability

Corrective action and Preventive Action

ATTACHMENTS

• Attachment-I – Document Issuance and Retrieval Record 
• Attachment-II – Additional copy Requisition form 
• Attachment-III – Document Requisition form
• Attachment-IV – Log book issuance and Retrieval Record
• Attachment-V – List of department code with Number
• Attachment-VI – Template for Annexure/Addendum
• Attachment-VII – Storage Period of Major Documents
• Attachment-VIII – Documents/Data  Destruction record
• Attachment-IX -Specimen Copy of Stamp
• Attachment-X- Template for list of authorized persons for issuance of controlled documents
• Attachment-XI – Request For Review or New Document Preparation

Label :

Attachment-XII – Logbook Issuance and Retrieval Label

DEFINITION & ABBREVIATION(S)

DEFINITION

Data: the quantities, characters, or symbols on which operations are performed by a computer, which may be stored and transmitted in the form of electrical signals and recorded on magnetic, optical, or mechanical recording media or factual information (such as measurements or statistics) used as a basis for reasoning, discussion, or calculation.

Documents: a written or printed paper that gives information about or proof of something.

Records: The facts, events, etc. that are known (and sometimes written down) about somebody/something/to write down or film facts or events so that they can be referred to later and will not be forgotten.

ABBREVIATIONS

SOP: Standard Operating Procedure

cGMP : Current Good Manufacturing Practices

HOD: Head of Department

CC: Change Control

GTP: General Test Procedure

DSC: Digital signature certificate

RESPONSIBILITIES

User department shall be responsible for:

Initiation /preparation of document. (SOP, STP/STS, format, Annexure, Attachments, worksheet and Labels, Protocol etc.).

Submitting the approved document to Quality Assurance (QA) for Preparation of master copy and control copy and issuance.

User department responsible for maintain the issued /controlled copies.

Head of User department/designee shall be responsible for:

All HODs shall be responsible for follow the procedure mentioned in this SOPs.

Quality Assurance department shall be responsible for:

Quality Assurance shall be responsible for maintaining and controlling of the documents as per this SOP and shall review the documents for compliance with the relevant documentation procedures.

Head Quality Assurance/Designee shall be responsible for:

Head QA or his/ her designee shall be responsible for compliance of this SOP.

Plant Head shall be responsible for:

To ensure the implementation of the defined system

PROCEDURE

SAFETY/PRECAUTIONS/EHS

The formats for all SOPs in various departments shall be kept identical.

Only Controlled copies of SOPs shall be made available at the point of use.

No further photocopy/Xerox are allowed to Controlled copy (if found shall be treated as Uncontrolled copy/copies).

Stapler pin shall strictly prohibited on MASTER DOCUMENTS, preserved in PVC    folder/sheets.

Only blue colour ball pen used for filling of cGMP / cGxP documents such as BMR  / BPR / Protocol / requisition etc.

All the documents shall be the part of QMS documents and QMS shall comprise the following:

Quality Manual: The Quality Manual shall contain a statement of the company’s Quality Policy and Quality Objectives. It shall include the systems being followed for the implementation of the Quality Policy. Quality Manual shall be prepared by QA personnel and shall be approved by QA Head.

Master Documents: These are detailed documents for implementation of Quality Management System covering all activities that individually or collectively influence the quality of a product, whether directly or indirectly. These include facility layouts, Master Formula Records (MFR), Batch Manufacturing Records (BMR), Batch Packing Records (BPR), specifications and standard test procedures of materials and products, Qualifications / Validation protocols and SOPs. These documents are prepared by user department personnel and shall be approved by QA Head.

Only sign/date to be maintained manually and other information shall be printed in master formats, list and attachment.

We proposed to change the Digital signature in place of Manual signatures for prepared by, checked by, reviewed by, approved by & authorized for preparation of documents. (BMR, BPR, MFR, MPR, SOP and all their attachment, Protocols and Reports).

If authorized DSC person not available in premises and any other type error face during creation of master documents. Then manually procedure shall be follow without any QMS document complies.

Records: Records can be categorized as:

Primary records (original raw data): e.g. executed batch records, analytical records, log books, maintenance records, calibration records, Temp-RH records, pressure differential records.

Secondary records/documents: These are generated as report / certificate using primary raw data.

Sundry records/documents: These are records/documents which do not have direct effect on GMPs.

All the documents shall be prepared by taking into account the relevant statutory requirements.

All documents shall be written by using “Arial” font, size 11.

All documents shall be identified and traced by a unique title & unique document number.

English language shall be used in all documents.

Any allotted document number must not be allotted to any other document.

No hand written document shall be considered as a master document.

User shall prepare documents or make data entry in records by considering the following points:

Be sensitive to GMP compliance.

Record activity immediately and correctly.

Check entry of records for accuracy.

Sign and date immediately on recording.

Preserve all records / evidence in case of deviation or OOS.

Checker/ Reviewer shall check/ review the documents by considering the following points:

Verify record for adequacy/ accuracy.

Sign and date for review.

Approver shall approve the document by considering the following points:

Ensure adequacy/ accuracy of document.

Sign and date on approval of document.

Preparation of the Document(s):

For initiation of any new document generation, the initiator department personnel shall prepare the draft document with “DRAFT” watermark as shown below:

After completion of drafting the document, the user shall send it to his Department Head for review.

Department Head shall review the draft document, put the remarks or suggestions if any and forward it to QA department.

QA shall circulate the draft copy of document to the other concern interlink departments for review (if required).

After receiving the comment from other concern interlinks departments (where applicable), QA personnel shall review the draft copy of the document, write the comment (if any).

After QA comment on the draft copy of the document, QA personnel send it to QA Head for comments, if any.

QA Head or his/her designee shall review the draft copy of document and put the comments, if any, and finally QA Head or his/her designee shall approve the draft copy of document by making his initial.

After approval of the draft copy of document, QA forwards the finalized draft document to initiator department for final print.

Initiator department takes printout of the final document in black ink on A4 size white paper (on one side of the paper only).

Initiator department’s officer signs the document in “Prepared by” column and the initiator department’s head signs in “Checked by” column and forwards the signed document with the final draft document to QA for approval.

In case of rejection of the draft copy of document by Head-QA or his/her designee, the same shall be maintained by QA personnel.

Once the concerned document is approved by Head QA, initiator department shall conduct training on the document and evaluation of training there upon.

Note: If a department prepares a document that involves other interlink departments(s) in its execution, and then the persons from other concern department(s) shall also be trained.

Department Head shall ensure that the training is imparted to all concerned and the initiator department shall forward the training record to QA.

Annexure Shall be attached or used wherever if space is not sufficient for writing or used as a reference purpose. It shall be prepared as per Attachment-VI

An addendum is used to clarify and add things that were not initially part of the original Documents/Contract/Agreements. Numbering for annexure/Addendum shall be as follows: XXX/A-NN and XXX/AD-NN

Where

XXX: Shall Be SOP No.or /Report No./or /Form No./List No.

/ : Shall be slash

A: represent Annexure/

AD: represent Addendum

NN: Shall be the serial no, of annexure for SOP/Report/Form No.

e.g first annexure for change control form shall be …………. & second will be ………

e.g First Addendum for vendor list shall be written as ML/QAD/AVL/24/00/AD-01.

Addendum/Annexure approval contain only two person from concern department i.e. prepared by and checked by Colum only.

Master copies of documents

Master copy shall be an approved original copy of document and shall be prepared by QA by stamping of “MASTER COPY” stamp in red color on each page of the document at left top corner position. Refer Attachment-IX

Master copy shall be kept in the custody of QA.

Each master list shall be allocate unique Number. Numbering of Master list shall be as follows:

ML/XXX/YYY/ZZ/NN

Where,

ML: stands for Master List

XXX: indicate subject Code (e,g, SOP for Standard operating procedure, AVL for approved vendor list).

YYY: Indicate Department Code (Refer Attachment-VI).

ZZ: Indicate last two digit of current year. (e.g 2023 shall be represent as 23).

NN: Indicate revision no. of the list starting from 00.

Controlled copies of documents

Controlled copy shall be prepared by QA by photocopy of master copy with stamping of “CONTROLLED COPY” stamp in Green colour in the top right corner of each page.

Controlled copy is a distribution copy of a master document and shall be distributed to users their intended use.

Copy No. of the document shall be written in the following manner: Department No. / No.’s of copies send to departments (for department code No. refer Attachment-V), e.g. for QAD controlled copy, copy No. shall be 01/02, in which “01” represents the department code No. as per Attachment-V (and “02” represents that second copy of document shall be issued to QA.

Issuance and retrieval of controlled documents shall be maintained as per Attachment-I

Uncontrolled copies of documents

Uncontrolled copy shall be distributed on need as a reference copy for external regulators, any auditors and governmental authorities.

Uncontrolled copy shall be prepared by QA by photocopy of a master copy with stamping of “UNCONTROLLED COPY” in Blue colour on each page top center of the document.

Issuance of uncontrolled copy shall be maintained by QA as per Attachment-I. Retrieval of uncontrolled copy shall not be done.

Issuance & control of documents

All documents like validation protocols/ reports, qualification documents, SMF, VMP, Quality Manual, manufacturing master formula, specification, STP, BMR, BPR, method validation protocols, stability protocols and reports, log books of equipment and instruments etc. shall be under the control of Quality Assurance department.

Controlled copies of the documents, if needed, shall be distributed to user department(s) by QA.

All the external calibration data of equipment / instruments shall be kept / maintained by the QA department e.g. QA shall maintain all the data of calibration for thermometers, gauges, PLCs, motors, pumps etc. QC shall maintain all the external calibration data of its analytical instruments such as HPLC, auto titrator, spectrophotometer, balance etc.

All the data maintained in laboratory software / production PLCs shall be password protected.

A printed hard copy of analytical & processing data, duly signed by doer and checker, shall be preserved along with the respective documents, e.g. chromatograms, reports and electronics print outs (if any), in QC department.

All data shall be executed by doer, checked by supervisor or above and verified by QA (if applicable).

Issuance and retrieval of the entire controlled document is governed by QA.

For issuance of any type of controlled document, user shall fill the Documents Requisition Form as per Attachment-III , which is maintained by QA documentation personnel.

Issuance of logbook shall be maintained as per Attachment-IV

Logbook issuance number will be given as:XXX/YY/ZZZ

Where   ‘LB’ – Log Book.

‘XXX’- Department Code (refer Attachment-VI)

‘YY’- Year of Issuance.

‘ZZZ’- Serial Number of logbook.

For Example, first logbook of QA department shall be QAD/23/001Second logbook of QA department shall be QAD/23/002.

“Logbook Issuance label shall pasted on the cover of logbook which shall contain all information related to Logbook as mentioned in Attachment-XII (Label No.

The new copy of the document shall be issued only after retrieval of the old copy of the same document.

Separate issue procedure for followed for BMR, BPR and Worksheet issuance.

If any additional copies of documents are required, a request shall be made to Head – QA/Designee in the specified format as per Attachment-II

In case of BMR/BPR, additional sheets, document like worksheets, Raw data sheet, paper formats/Attachments/ worksheet either daily/ monthly/quarterly or yearly basis shall be issued by QA Department along with green colour round stamp of “………..” on all pages as per Attachment-IX

Issuance of documents through software by using scan copy of master documents. Digitally issuance by using Software to be used for all type documents Issuances, issued by name and current date issuance is print in header part right side.

In case of any technical fault such as networking or internet problem or if software have any issue then alternate method of issuance shall be used for controlled documents. As in case of BMR/BPR “ISSUED BY QA” in green colour shall be affixed on front page and other remaining pages top right corner with sign and date in blue pen only and documents like analytical worksheet, raw data sheet, paper formats/ attachment shall be stamped by “ISSUED BY QA” in green colour at top right corner on each pages and signed by Q.A in blue ink ball pen shall be continue in use for controlled documents.

Trial batch BMR shall be issue as per above Mentioned procedure.

Validation batches & stability Batches BMR & BPR shall be issue as per as per above Mentioned procedure with stamping “VALIDATION BATCH” Stamp in Blue colour, on front cover file of BMR and BPR & below Issuance stamp on first page of BMR and BPR with sign & date & “STABILITY BATCH” Stamp in Blue colour, on front cover file of BMR with sign & date.

“REVIEWED COPY” stamp shall be affixed all certificates provided by vendors, etc. in blue colour at bottom right corner on each pages.

“REFERENCE COPY” with sign and date shall be affix on Photocopying of reviewed vendor certificate for other department, traceability certificate, supporting attachments and document send for mankind CQA or its subsidiary group of companies in blue colour below footer signature on each pages Refer Attachment No-IX for stamp.

“INVALID DATA” with sign and date stamp shall be affix on all invalid data in blue colour at bottom center of each page and attached with the VALID DATA. Refer Attachment No-IX for stamp.

 “QA VERIFIED” stamp shall be affix on pre dispatch inspected corrugated box before batch release in blue colour on front top right corner with sign and date by IPQA person. Refer Attachment No-IX  for stamp.

Date stamp in blue colour ink used for effective date and next review date shall affixed at its designated place.

Specimen for stamps are mentioned in annexure titled as Specimen for stamps as per Attachment-IX

Review of the Documents

All the documents shall be reviewed ±30 days  the ‘Review Date’ assigned on the concerned document or review frequency mention in document.

Concerned Department person shall issue “Request For Review of Document” form as per Attachment-XI for review of document and after review submit the Document to QA deptt along with the review form.

Revision procedure of documents shall be of two types:

• Routine or periodic revision
• Provisional or conditional revision

Routine or periodic revision: Revision of a document as per assigned review period of respective documents.

If there is no change in SOP/Documents, concerned person submit the Form (as per Attachment-IX) by commenting in form. Then QA Personal shall be extending the Date in given column of documents for next review period with stamping by date. However, the SOP shall be essentially revised after every 4 years, even if there is no change.

Document revised by routine or periodic revision shall be revised with change control and version no. of the document shall be changed.

If any change is required in the respective document, then such type or revision shall be initiated by “Change control form” as given procedure in the SOP on change control Management .

Provisional or conditional revision: Revision of documents before the assigned review period of respective document.

If any change is observed in the respective document before the assigned review period, the revision shall be initiated only through “Change control form” as given procedure in SOP on change control Management.

All the documents shall be reviewed by QA in the following manner:

The initiator department shall undertake the review of the concerned document as a draft copy.

The initiator department shall forward the reviewed document with comments to Quality Assurance department.

QA shall check the comments. If required, QA can send back the same to the initiator department for further information on the subject and/ or to other interlink department(s) for the comments, if required.

After receiving the final comments from the concerned departments, Quality Assurance shall assess the proposed changes. If proposed changes are acceptable to QA, then QA Head shall approve the draft copy of the respective document.

QA shall forward the approved draft copy to the initiator department for preparation of the final copy of document.

After incorporating all comments, the initiator shall take a print of the final copy of the document, the initiator department’s officer shall sign the document in “Written by” column and the initiator’s department head shall sign in “Checked by” column and the signed document with final draft document shall be forwarded to QA for approval.

Revised copy of the document shall be approved by QA Head.

After approval of the document follow the above mentioned procedure of preparation of the master copy, controlled copy of a document, issuance and control of documents.

Distribution and Retrieval of the Documents

All the controlled documents shall be distributed and retrieved by QA.

Distribution and retrieval of the all the controlled and / or uncontrolled documents shall be done using the form titled “Document Issuance and retrieval Record” as described in Attachment-II.

Archiving of documents

Archiving of all documents shall be done by QA.

QA shall arrange all documents department wise so that it can be easily identified and traceable.

All the records received should be reviewed and then stored in the designated area according to the sequence no.

The master copy of superseded document shall be retained by the QA and stamped as “SUPERSEDED” at middle diagonally of each pages.

Discontinued SOP and documents shall be preserved in QA department and stamped “OBSOLETE” on Master copies, in middle diagonally on page in red ink.

Obsolete copies shall be archived in QA.

Footer and effective date will be remove from all loose formats which is issued by QA department for routine use.

Footer and effective date will be remove form printed log book from outside party when use for routine purpose.

Retention Period of Documents.

Documents shall be archived and retained at QA as per their storage period.

Storage period of major identified documents shall be as per Attachment-VII

Handling of Records

Each concerned department shall be responsible to fill all the records relevant to the approved written procedure.

The documented data or records shall be forwarded to QA at appropriate intervals.

Each concerned department shall co-ordinate with QA in maintaining the reference documents like machine manuals, protocols etc.

raining questioner and answer sheet will submitted with SOP when prepare the master copy after approval  and after training questioner feedback form not issued by QA department it will be handle by concern department HOD and training coordinator for routine purpose.

Pre-printed name and designation in all master formats, annexure, attachment, master list, MFR and MPR etc.

Destruction of documents and records

After expiry period of documents, QA personnel shall destroy the documents by shredding.

After destruction of documents QA personnel shall make necessary entries in “Document/Data Destruction Record” as per Attachment-I.

REVISION HISTORY:

New SOP Prepared.