Issuance and Retrieval of Control documents

1.0 Objective
To lay down a procedure for issuance and retrieval of controlled documents

(e.g. SOP, STP, Formats, Printed logbooks, Register, other).
2.0 Scope
This Standard Operating Procedure is applicable for procedure of issuance and retrieval

of controlled documents like SOP, STP, Formats, Printed logbooks, Register, other from

QA department to all departments at the formulation plant of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive QA shall be responsible for issuance and retrieval of Controlled

Documents to user department as per requisition given by the user Department.
3.2 Concern Department Head shall be responsible for implementation of this SOP.
3.3 Head QA or his/ her designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
STP : Standard Test Procedure
GTP : General Test Procedure
QA : Quality Assurance
No. : Number
5.0 Procedure
5.1 Concern department shall request to QA department for issuance of controlled

documents on form of “Requisition for controlled document issuance” as per Annexure- 1.
5.2 The request shall be generated by user department for the issuance of controlled documents formats, register etc.
5.3 Request shall be generated for the issuance of new format/ register when the previous

issued documents completely used/ filled and the previous documents shall be retrieved by

QA before issuance the next controlled documents e.g. format/ register/ log book.
5.4 Incase of SOP/ Specification/ Art work / STP/ GTP shall be issued of next version / revision

when the all distributed copies of previous version retrieved and filled the retrieval and issuance record in the Annexure-2.
5.5 In case o f any type of error in controlled document requisition, then QA Officer/ Executive

shall send the request back to the user department for correction.
5.6 QA Officer / Executive shall be stamp “controlled copy” / “controlled document”

on non text matter of controlled document.
5.7 QA Officer / Executive shall issue the controlled document to user department after

recording the details of record as shown in Annexure- 2.
5.8 QA Officer / Executive shall destroy the unfilled formats either manually or by paper

shredding machine immediately after receiving from user department.
5.9 For issuance of controlled document
5.9.1 For issuance the controlled document, concern department generate the request form as per Annexure-1.
5.9.2 Controlled Document shall be issued after receiving the request form issuance of

Controlled document from user department. QA Officer / Executive shall paste label

on every front side of documents as per Annexure – 3 for controlled documents.
5.9.3 After approval from QA, the same shall be issued to user department with stamp

of “controlled copy” / controlled document” on label with initial and date. The issuance

details shall be recorded as per Annexure 2.
5.9.4 QA person fill the all details in label and respective record.
5.10 For Retrieval of controlled document
5.10.1 After completion of controlled document just like format, register, log book and other,

user department shall submit the filled format, register, log book and other to QA documentation

cell and QA documentation cell In-charge shall record the retrieval details as per Annexure-2.
6.0 Forms and Records
6.1 Requisition for Controlled Document Issuance – Annexure-1
6.2 Issuance and Retrieval Record of Controlled Documents – Annexure-2
6.3 Controlled Document Label – Annexure-3
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance, Production, Engineering, Quality Control,

Warehouse, and Personnel & Administration.
8.0 History