SOP FOR PREPARATION, APPROVAL, REVISION, CONTROL OF LISTS
PURPOSE: To lay down a procedure for Preparation approval revision and control of lists.
SCOPE: This procedure is applicable to all type of lists prepared.
RESPONSIBILITY:
Preparation of SOP: Officer Quality Assurance
Checking and Review of the SOP: Officer QA
Approval of the SOP: Executive QA/ Designee
Authorization of SOP: Head QA/ Designee
Preparation of List: User Department
ACCOUNTABILITY: The accountability of implementation and compliance of the SOP is Head Quality Assurance.
PROCEDURE: Various lists shall be prepared as required by respective departments but not limited to, for Example:
- List of SOP
- List of Equipment’s
- List of Authorized persons
- List of Product
- List of Process Validation
- List of Specification
- List of Standard Test Procedure
All lists that are not governed under any SOP shall be prepared.
List shall be approved by Head QA (Note: In case of multiple pages list the approval shall be on last page.)
The numbering system of list shall be follows DC/LNNN
Second
The First and Second letters of the alphabet denoting the Department Code” for which list is being prepared for the code of department is given as Per SOP for SOP.
Third letters denote “/” (which denotes slash)
Fourth letter denotes “L” (which denotes List)
5th 6th and 7th letter denotes “serial number of List” three-digit number starting serially from 001).
Every department shall prepare a “List of Lists” for all the list prepares by the department.
After receiving the soft copy of List from the concern department. QA Documentation cell person shall review the documents for its accuracy and adequacy such as but not limited to:
- Format & Format No.
- Page Numbering
- Typographical errors
- Compliances with Change control
- Other affected documents
QA Documentation cell person shall take the printout and this hard copy shall be forwarded to concern department for signature.
After approval of list, put the effective date.
QA Document control personnel shall stamp in each page of the list in green ink with a stamp, which has the words “MASTER COPY” so as not to obscure text present on the upper top right side of the page.
QA Document control department stores all Master Lists.
Make controlled copies by photocopying each master Lists and stamp in blue ink with the word “CONTROLLED COPY” on the bottom right corner of each page. Issue the Controlled copy as per SOP.
If specifically required by any Regulatory Authority or Auditor, a copy of document shall be provided which shall be stamped as “UNCONTROLLED COPY” in blue ink at bottom middle.
Master List will be revised as per requirements and shall be updated in list of lists.
REFERENCE:
SOP for SOP
Document Control System