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SOP for Quality Management System (Documentation) in Pharmaceutical Industry



  1.  Objective:

To lay down a procedure for origination and review of the Site Master File, Quality     Manual, Quality Policy, SOPs, forms and logs.

  1. Scope:

This procedure is applicable for following documents:

– Quality Manual/Policy

–  Site Master File

–  Standard Operating Procedures (SOP)

–  Forms

–  Logs

  1. Responsibility:

All department

  1. Procedure:

4.1 Any member of staff may initiate the requirement and issuance of a new GMP       document or the amendment of existing one.

4.2 Changes in documents shall be made via change management system; it can be also made and controlled via the revision history of the document without addressing through the change management system if they are minimal and they do not impact any other process or document. Below are the examples of such changes which do not require change management system:

– Minor typographical error

– Periodic revision of document without any other changes

– Changes related to clarity of document

4.3 Change management system shall contain impact assessment and shall assess the impact on other document and process, as well as impact on the responsibilities.

4.4 Wherever applicable document shall contain revision history and make reference of change request in revision history along with brief discussion on changes.

4.5 Each GMP/QMS document shall have unique number along with revision number to   reflect the number of revisions.

4.6 Each SOP shall have following sections:

– Purpose

– Scope

– Responsibility

– Procedure

– Abbreviations

– Annexures

– References

– Revision history

4.7 All QMS document shall be written in Times new roman font size 12; heading and       subheading should be written in bold and font size maximum up to 14 can be used.

4.8 Each section shall be numbered and all subsection or paragraph within one section should be numbered accordingly.

4.9 Responsibility section of SOP shall designate the department who is the responsible     for the activities/process described by the document.

4.10 Each SOP shall have effective and next revision date.

4.11 Effective date shall be established in line with timeline necessary to complete the       training of all relevant department.

4.12 Training shall be completed within 15-20 days after approval, however extension is   acceptable based on complexity of the document.

4.13 Where SOP is revised with minor change or revision updated, in such case SOP can be made effective immediately upon approval.

4.14 Forms and logs associated with SOP shall be part of respective SOP annexure.

4.15 Log shall be available to list all available logs/forms in organization.

4.16 Each log and form shall have unique number, revision number and revision history.

4.17 All forms and logs shall be issued in either editable or non-editable version depending on type and usage of forms/logs.

4.18 Master copy of all SOPs, forms/logs shall be maintained.

4.19 Training period for site master file, quality manual/policy is 15 days from the date of approval.

4.20 The forms/logs become effective immediately upon approval, unless they are part of SOP in which case training period applies to related forms and logs.

4.21 Site master file, SOP, quality manual/policy and forms shall be reviewed every 3 years unless more frequent review is deemed necessary.

4.22 Each document shall be reviewed and approved by the relevant competent person.

4.23 All QMS and GMP document should be written in blue or black ink. Hard copy of the documents should be available. Electronic or scanned copy can be maintained along   with hard copies wherever required.

4.24 Document outside the organization shall be issued as “uncontrolled copy”.

4.25 All QMS/GMP documents shall be retained as per document retention policy.

  1. Abbreviations:

QMS: Quality management system

GMP: Good manufacturing practice

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