SOP on Preparation, Approval, Review and Control of Operating Guidelines
Objective : To lay down a procedure for the preparation, approval, review and control of Operating Guidelines.
Scope : This Standard Operating Procedure is applicable for the preparation and implementation of all Operating Guidelines.
Responsibility :HODs of respective department shall be responsible for preparation of Operating Guideline (s) ,Head-QA shall be responsible for Implementation and Compliance of this SOP.
OG : ‘Operating Guideline’: 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.
Procedure :
Preparation and Approval of Operating Guidelines
All Operating Guidelines shall be written in clear and easy to understand language.
All the OGs shall be generated on computer in the format and shall be typed preferably in font face ‘Times New Roman’ with font size ‘12’ or with other appropriate font size.
‘Title’ of the OG shall be brief and self descriptive in nature.
Initiator department shall mention its name in the left hand side of the top of the document.
‘OG No.’ shall be denoted in thirteen characters as described below
The first character shall always be alphabet ‘G’ for ‘Guideline’
The second character shall denote the location of the formulation plant(s) e.g.
Alphabet “A” shall represent OG common for ‘All’ plants,
Note: In case, the first letters of two locations are same, then any letter of the new location’s name that is not matching with the first letter of the existing locations’ name can be used while numbering the OG for that location.
The third character shall be alphabet ‘F’ denoting ‘formulation’.
The fourth character shall be a ‘_’(dash)
The fifth and sixth characters shall depict the department code.
The seventh character shall be a ‘_’ (dash).
The eighth, ninth and tenth characters are numerals which shall denote Serial Number of the OG. The first OG of any department shall be 001. The subsequent serial numbers shall be 002, 003, and so on.
The eleventh character shall be a ‘_’ (dash)
The twelfth and thirteenth characters shall denote the Revision Number of the OG. The first version of any OG shall have Revision Number. ‘00’. The subsequent revisions shall be 01, 02 and so on. For example: the first OG of Quality Assurance department common for all formulation plants shall have the number GAF-QA-001-00. Similarly, first revision of the first production OG for Ahmadabad formulation plant shall be GAF-PD-001-01.
‘Effective Date’ is the date when the content of OG becomes operational for the user department(s). It shall be given after authorization of proposed OG by QA department in DD-MM-YY format
Initiator department shall conduct training of the OG and evaluation of training thereupon, as per the SOP titled ‘Training procedures’ , once the concerned OG is authorized by Head, QA.
Note: if a department prepares an OG that involves other departments(s) in its execution, then the persons from this (these) department(s) shall also be trained as per SOP and the training records generated shall be maintained by the respective user departments.
After completion of training on OG, besides acknowledging the date(s) of training on OG, the initiator department shall forward the OG to QA for putting ‘Effective Date’ on it and hence making its
The ‘Next Review Date’ shall be after two years from the Effective Date of the OG, given by QA department in DD-MM-YY format. Every OG shall be reviewed at least two months before the Next Review Date or earlier, if any amendment is required.
‘Page No.’ shall be numbered as specific page number of the total pages of the OG e.g. first page of OG of total 05 pages shall be 01 of 05.
Operating Guideline shall be prepared and checked by two individuals who shall be involved with implementation of the OG and accordingly shall write their names and sign with date in columns “Prepared by” and “Checked by”.
HOD or his / her designee of concerned department shall sign in the column ‘Approved by’
Head, QA or his / her designee shall sign in the column ‘Authorized by’ hence authorizing for implementation of the proposed OG
Note: All the entries made in hand by the concerned personnel shall preferably be in black ink only except for ‘Effective Date’ and ‘Next Review Date’ which shall be in blue ink. Ink of good quality shall be used for the purpose.
The typical format of operating guideline shall contain the following headings:
Objective: as first point; an overview of the intention of preparation of operating guideline shall be briefly mentioned under this heading.
Scope: as second point; describes the site(s) / location(s) / plant(s) and / or departments to which the operating guideline is applicable.
Responsibility: as third point; specifies designation of the personnel and name of department that shall be responsible for implementation and compliance of the operating guidelines.
Definition: as fourth point; describes the meaning or explanation of term(s) which is (are) not common or having any specific meaning and expansion of abbreviation(s) used in operating guidelines.
Guidelines: as fifth point; 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: as sixth point; It shall contain appropriate formats, specimen, specimen labels, etc. needed to record the compliance of the guideline, wherever applicable.
Distribution: as seventh point; describes the distribution of OG to various concerned departments
History: as eighth point; history shall contain a chronological record of significant changes / modifications / editing an OG in brief, maintained in three columns, namely: ‘Date’, ‘Revision Number.’ and ‘Reason for Revision’
All the headings shall be written in bold with first letter in capital.
Narrative text of each heading shall be aligned below the heading, not after the length of the heading.
An OG shall be printed on one side of standard A-4 size paper of appropriate quality in black ink.
OG Form(s) if any, their Number(s), shall be mentioned at the left hand side at the bottom of each page. Sixteen or Seventeen characters shall constitute the form number of the form(s) attached to an OG.
The first ten characters of the form number shall be derived from the concerned OG and the remaining six characters shall be as follows
The eleventh character shall be a ‘/’ (slash).
The twelfth character shall always be ‘F’ which denotes ‘Form’.
The thirteenth (and fourteenth, in case with seventeen characters) character shall denote the Form Serial Number ranging from 1 to 99 (a single digit number from 1-9 and double digit number from 10-99)
Note: An OG containing more than nine forms shall have forms’ numbers with seventeen characters instead of sixteen characters.
The fourteenth (or fifteenth, in case with seventeen characters) character shall be a ‘_’ (dash).
The fifteenth (or sixteenth, in case with seventeen characters) and sixteenth (or seventeenth, in case with seventeen characters) characters denote the Revision Number of the form. The first version of any form shall have Revision Number ‘00’. The subsequent revisions shall have Revision Number 01, 02, and so on.
for example: Form No. GAF-QA-001/F9-00 is the first version of the ninth form of first OG of quality assurance common for all formulation plants.
If a form or a record of an OG is relevant to another OG, the attached form or the record shall bear the Form No. assigned for the initial OG, e.g. if form GDF-PD-002/F1-00 of second OG of production department for Goa formulation plant is required to be attached in OG, GGF-PD-015-00, the form shall have the same number as in its mother OG i.e. GGF-PD-002/F1-00.
If a form of an OG needs some change(s) and these changes are not affecting the text of OG then the form shall be revised as per SOP titled ‘Document and Data Control’ SOP.
Any OG that addresses the recording of an operation or an activity in logbooks, the logbooks shall be prepared accordingly. The format (as discussed in the concerned OG) for recording in logbook may or may not carry the form number.
The user department shall forward the draft(s) of OG under preparation, to QA department for comments and necessary input, if any. Once the OG is finalized, the OG shall be forwarded with signatures in the respective columns to QA for ‘authorization’ along with its final draft. The drafts shall be destroyed afterwards.
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(s) followed or additional step(s) followed shall be recorded in ‘Additional Input/Deviation Record’ and on the basis of data generated thereupon can be used for revising the concerned OG.
Review and Control of Operating Guidelines
After authorization, Head, QA or his / her designee shall put dates in ‘Effective Date’ and ‘Next Review Date’ columns in DD-MM-YY format. The effective date shall be within thirty days of the authorization date.
Master Copies of all OGs shall be retained with Quality Assurance department. All pages of the original copy shall be stamped as ‘MASTER COPY’ on the front side of each page.
Quality Assurance department shall distribute the controlled copies of the OGs to the relevant departments. For preparation of controlled copies, photocopies of the master copies shall be taken and each page shall be stamped as ‘CONTROLLED COPY No.___’ on its front side with initials of the Quality Assurance personnel.
The record for issuance and retrieval of OGs shall be maintained on form ‘Operating Guidelines (OG) Distribution and Retrieval Record’.
If Quality Assurance distributes any copy of any OG, on which it has no control, each page shall be stamped as ‘UNCONTROLLED COPY’ with initials of the Head, Quality Assurance or his/her designee.
The additional controlled or uncontrolled copy shall be requested from QA, if required, mentioning the reason through ‘Requisition for Additional Controlled and / or Uncontrolled Copy of OG’ .
QA shall circulate updated list of OGs to all departments periodically.
Any revision in OG occurring on or before the Next Review Date shall be processed through Change Control procedure as defined in SOP titled ‘Change Control’
All the OGs shall be reviewed once in two years. QA shall identify the OGs at least two months before approaching the end of two years from the effective date. QA shall fill ‘OG Review Form’ and forward the form to the concerned initiator departments.
The concerned department shall review the Controlled copy of OG at their end and put their opinion in the respective columns of the form. The review work shall be completed within twenty days of the receipt date of the form at the concerned department. Thereafter the form shall be reverted back to QA.
Note: An OG shall be assessed for the consistency in its implementation during the period of its use i.e. no more or further deviations or additional steps are being followed, by HOD or his / her designee of the concerned department. If any OG qualifies against the above mentioned criteria then that OG can be converted into SOP by the user department following change control procedure and the affected OG shall be retrieved from the user department through its ‘Operating Guidelines (OG) Distribution and Retrieval Record’ sheet indicating final status of the that OG, by QA personnel.
After receiving the filled form from the respective department QA shall dispose the review process, in following manner.
The OG that needs revision shall be revised through Change Control procedure as defined in SOP titled ‘Change Control’ and that which does not need revision or change, the concerned Master Copy and controlled copies of that OG shall be stamped in blue ink bearing following information by QA Representatives authorized by QA Head for different locations.
QA representative shall fill the date on which the stamping is being done in the column ‘Reviewed on’.
‘Effective Date’ shall be an on-or-before-date to the date mentioned in the column ‘Next Review Date’ of the OG under review.
‘Next Review Date’ shall be two years after the ‘Effective Date’.
QA representative shall put his/ her signature in the column ‘Authorized by’
Note: Stamping shall be done on the backside of every page of the OG and QA representative shall put another stamp in blue ink bearing following information :REVIEWED
Over the columns for ‘Effective Date’ and ‘Next Review Date’ of every page of OG.
With the option of Stamping procedure, review of the OGs for no change(s) shall be done once only. The next review of the same OG shall be done through reprinting with change in its revision number (without raising change control for no change) e.g. Operating Guideline with OG No. GAF-QA-005-02, if is being stamped for no change in that OG, then that OG when reviewed next time with reprint option shall be numbered as GAF-QA-005-03 even for no change in the OG.
If an OG is being revised through Change Control, at that time, if any Form of that OG needs modifications, the same shall be done on the basis of the same change control; there is no need to follow SOP titled ‘Document and Data Control’; SOP.
Head, QA shall ensure retrieval, reconciliation and destruction of all Controlled Copies. The destruction details shall be written in the respective ‘Operating Guidelines (OG) Distribution and Retrieval Record’ by QA personnel. The old master copy shall be stamped as ‘OBSOLETE’ and shall be retained for a period not less than seven years from date of obsolescence of the master copy.
The records like forms, logbooks, etc. maintained against the requirements of OG, which has been made obsolete, shall be retained for a period not less than seven years from the date of obsolescence of the Master Copy of the OG, by the concerned department.
For operational purpose, if any OG or a portion of it is required to be translated in vernacular language, the same shall be done by the Head of the concerned department or his / her designee. The vernacular OG shall be made on the format defined.
If there is a revision in the original OG, the vernacular OG of the same may or may not be changed as per the discretion of the Head of Department or his / her designee. If there is no change in the translated text, the OG Number of the vernacular OG shall be changed to the new version by cutting the old version with sign and date by Head of Department or his/her designee.