Operating Guidelines in Pharma -A Brief Introduction

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1.0 Definition

‘Operating Guideline’ (OG) :- A set of instructions directing how to execute an activity. The Operating Guidelines shall be prepared for the execution of an operation, which has the tendency to vary over a period of time by virtue of its nature. The Operating Guidelines shall be indicative in nature.

2.0 Preparation and Approval of Operating Guidelines

2.1 All Operating Guidelines shall be written in clear and easy to understand language.

2.2 All the OGs should be generated on computer in the specific format (for e.g. specimen for one of operating guideline is given in below) and shall be typed preferably in specific font type and font size as per individual pharma company policy (by following SOP On SOP & Good Document Practices Guideline or relevant document of firm ).

2.2 ‘Title’ of the OG should brief and self descriptive in nature.

2.3 ‘OG should have a specific identification No. ( it can be put up by following SOP on SOP  or relevant document of the firm)

2.4 Operating guideline should have an ‘Effective Date’ from when the content of OG becomes operational for the user departments. It shall be given after authorization of proposed OG by QA department.

2.5 Before being effective, a training with record should be conducted for the related personnel on OG..

Note: if a department prepares an OG that involves other departments in its execution, then the personnel  from this departments should also be trained as per respective SOP.

2.6 After completion of training on OG,it can be effective .

2.7 An OG required a review date also that can be as per SOP on SOP of the firm.

2.8 Every page of OG should have page no.

2.9 Operating Guideline should be prepared and checked by minimum two individuals who are involved with implementation of the OG, QA should approve the document.

2.10 The typical format of operating guideline should have minimum following contents or as defined in firm policy:

  • Objective: An overview of the intention of preparation of operating guideline should briefly mentioned under this heading.
  • Scope: Describes the site(s) / location(s) / plant(s) and / or departments to which the operating guideline is applicable.
  • Responsibility: Specifies designation of the personnel and name of department that should be responsible for implementation and compliance of the operating guidelines.
  • Definition: Describes the meaning or explanation of term which is not common or having any specific meaning and expansion of abbreviation used in operating guidelines.
  • Guidelines: Describes the detailed guidelines to be followed in simple and clear sentences. It may include the details of all operations, operational conditions and precautions to be taken, if any, etc.
  • Forms and Records: It should contain appropriate formats, specimen, specimen labels, etc. needed to record the compliance of the guideline, wherever applicable.
  • Distribution: Describes the distribution of OG to various concerned departments
  • History: History shall contain a chronological record of significant changes / modifications / editing an OG in brief.

2.11 Since the Operating Guidelines are applicable for the execution of a variable operation, as per the need the user or doer may deviate or follow extra steps in addition to those specified in the concerned OG, in that case the deviation followed or additional step followed should be recorded.

3.0 Review and Control of Operating Guidelines

3.1 After authorization by QA department OG should have a master stamp in a specific place as following SOP on SOP or relevant document of firm

3.2 Master Copies of all OGs should be retained with Quality Assurance department.

3.3 Master Copy of OG should under go distribution, Quality Assurance department should distribute the controlled copies of the OGs to the relevant departments. For preparation of controlled copies, photocopies of the master copies can be taken  and each page shall be stamped as ‘CONTROLLED or as per company norms.

3.4 The record for issuance and retrieval of OGs should be maintained on form ‘Operating Guidelines (OG) Distribution and Retrieval Record’ ( A specimen format attached).

3.5 For other usage, OG can be distributed by stamping uncontrolled stamp or as per firm policy.

3.6 All the OGs should  reviewed once in two years or as per specific time defined by firm.

3.7 The concerned department should review the Controlled copy of OG at their end and put their opinion. The review work should be completed in a specific time period defined by firm. Any revision in OG occurring on or before the Next Review Date should be processed through Change Control procedure

3.8 If an OG is being revised through Change Control, at that time, QA should ensure retrieval, reconciliation and destruction of all Controlled Copies. The destruction details should be written in the respective ‘Operating Guidelines (OG) Distribution and Retrieval Record’ by QA personnel.

3.9 The old master copy and relevant record shall be stamped as ‘OBSOLETE’ and shall be retained for a specific period defined by firm.

4.0 Specimens

6.1 Specimen for Operating Guideline Format

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6.2 Specimen for OG Distribution and Retrieval record

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