Eldon Henson

Your Company’s Name Effective Date:

Standard Operating Procedure August 15, 2002

Document Number: Title: Page:

QAP-001-01 Document Control System 1 of 4

1. PURPOSE
1.1. This procedure provides instructions for the generation, use, and control of all GMP-related doc-
uments. Specific requirements for document change control are included in other documents.

2. SCOPE
2.1 This procedure applies to all documents relating to pharmaceutical products manufacturing,
packaging, testing, or distribution at this site. This procedure applies only to the preparation
and maintenance of Quality Assurance (QA)-controlled documents. Change control is cov-
ered in other documents.

3. RESPONSIBILITY
3.1. Document Author or Preparer – any individual trained in this procedure may serve as author
for a document or change, however, any proposed document or change is subject to all re-
view and approval activities described in this procedure
3.2. Document Approver – any individual qualified by training, experience, education, and the
management of his/her area to comprehensively review a document, and render approval
for content, format, and cGMP compliance
3.3. Quality Assurance (QA) – overall control of the document system, all activities relating to
compliance with this procedure, and all cGMP requirements

4. DEFINITIONS
4.1. Effective date – the date a controlled document becomes official, and must be used as the
only reference for that activity
4.2. Form – a controlled document used to convey reference information, or designed to allow
recording of data to support pharmaceutical production and related activities
4.3. QA-controlled document – any Standard Operating Procedure (SOP), form, or other docu-
ment subject to QA review and approval, controlled issuance, controlled change, revision
control, and archive security
4.4. Revision history – record of all changes that have occurred to a document, and the rea-
sons for those changes
4.5. Standard Operating Procedure (SOP) – a written document that describes activities neces-
sary for cGMP compliance for pharmaceutical product manufacturing, packaging, testing,
or distribution.

5. REFERENCE DOCUMENTS
5.1. Procedures for changing documents are described in SOP ______ “Document Change
Process.”
5.2. Training on new or revised documents is described in SOP ______ “Training Documenta-
tion for New or Revised Documents.”
(Note to Reader: Examples of these SOPs are not included in this publication at this time. These
SOPs should include standard internal procedures for the activities of document changes and document
training, respectively. If you would like to review the Institute of Validation Technology’s SOP template
product line, visit www.ivthome.com for more information.)

48 I n s t i t u t e o f Va l i d a t i o n Te c h n o l o g y
 Eldon Henson

Your Company’s Name Effective Date:

Standard Operating Procedure August 15, 2002

Document Number: Title: Page:

QAP-001-01 Document Control System 2 of 4

6. PROCEDURE FORMAT
6.1 An established template for the format of procedures is available from the QA Document
Control group, and must be used for the generation of new SOPs.
6.2 All SOPs will have a standard format that includes the following components:
6.2.1 Descriptive, but not long, title
6.2.2 Final approval that includes Document Preparer, Department Approver, and QA final
approval
6.2.3 Revision history – a table that includes a brief description of the changes occurring in
each version, along with justification for each version change
6.2.4 Purpose – a statement on the reason for the document
6.2.5 Scope – a statement identifying any limits associated with the activities covered by
the procedure
6.2.6 Definitions – a definition for any new terms or terms requiring clarification
6.2.7 Responsibilities – a statement identifying any specific responsibilities outlined in the
procedures
6.2.8 Requirements – detailed statements outlining the specific requirements or obligations
included in the document

7. PROCEDURE NUMBERING SYSTEM

7.1 All SOPs and forms will comply with the following numbering system:
7.1.1 The numbering system to be used is illustrated as follows:
QCS – 001 – 00
7.1.2 In this system, the first two letters identify the primary department involved.
For example, a list of departments could be set up as follows:

Department Identifier Department Name

EN Engineering
GP General Plant
QA Quality Assurance
QC Quality Control
MR Maintenance and Repair
SP Solids Production

7.1.3 The third digit will identify the type of document.

Department Identifier Department Name
(Note to reader: These are
C Calibration only examples. The specific num-
F Form bering scheme you use may in-
M Method clude a significantly larger num-
P Policy ber of departments or document
S Specification types. This is presented merely
X Cleaning as an example for consideration.)

C o n d u c t i n g Au d i t s, G A P A s s e s s m e n t s, & C o r r e c t i ve A c t i o n s 49
Eldon Henson

Your Company’s Name Effective Date:

Standard Operating Procedure August 15, 2002

Document Number: Title: Page:

QAP-001-01 Document Control System 3 of 4

7.1.4 The next three digits will be a chronological number. The first document of each type
would be 001, etc.
7.1.5 The last two digits will be the version number. The initial version will be 00. The first
revision will be 01, etc.
7.1.6 All document numbers will be assigned by the QA Document Control group.

8. DOCUMENT ISSUANCE
8.1 All new versions of a document will include a new version number. This includes minor
changes made to correct typographical errors, etc. See SOP _____ “Document Change
Process” for details relating to the change process.
8.2 After all document approvals have been obtained on a new or revised document, the QA
Document Control group will assure that all required training has been documented. Only
after verifying that training is complete, can the document be issued. See SOP _____
“Training Documentation for New or Revised Procedures.”
8.3 Upon receipt of all training documentation, the QA Document Control group will determine
the effective date for the document. This date will be added to the document.
8.4 Issuance of new or revised documents will include the following steps:
8.4.1 Update the document index. The update will include adding the new document, or re-
placing the old version from the index.
8.4.2 Removal of the previous version of the document. For paper copies, this involves
physical retrieval of each old version. For electronic copies, the old version will be de-
activated or removed from the active index.
8.4.3 Paper copies will be stamped with the “Official Copy” stamp. This colored ink will iden-
tify that these copies are official and active.
8.4.4 Placement of the new or revised copy in the proper locations, along with the revised
index. Paper copies will be physically placed. Electronic copies will involve replace-
ment of active files to include the new index and document.

9. ACCESS AND PRINTING OF DOCUMENTS

9.1 In general, only the “official” copies of documents should be referenced. For example, only
on-line versions of electronic documents must be referenced, and only “official” stamped
paper copies should be used.
9.2 Copying or printing of documents is generally not allowed. However, controlled copies may
be obtained from the QA Document Control group. Printing of copies from electronic files is
allowed, only if the “Uncontrolled Copy” watermark is present and clearly visible. Upon copy-
ing or printing, each document must be signed and dated by the copying/printing individual.
9.3 Controlled copies or watermark prints are only valid for reference use, and must be de-
stroyed at the end of each working day.
(Note to reader: Control or printing of copies is a difficult topic. The activities listed in this document
are listed only as an example. Some firms choose to allow liberal copying or printing of documents.
Other firms prohibit any copying or printing. This section must be customized to your operation.)

50 I n s t i t u t e o f Va l i d a t i o n Te c h n o l o g y
 Eldon Henson

Your Company’s Name Effective Date:

Standard Operating Procedure August 15, 2002

Document Number: Title: Page:

QAP-001-01 Document Control System 4 of 4

10. DOCUMENT STORAGE AND PHYSICAL CONTROL

10.1 All original signed documents and historical records will be stored by the QA Document
Control group in secured storage units.
10.2 Only individuals authorized by the QA Document Control group may have access to stored
documents.

11. REVISION LOG

Revision Date Section(s) Description

00 N/A Original Issue

12. APPROVALS

Authored By:_________________________________ Date:_________________________

Reviewed By: ________________________________ Date:_________________________

Approved By: ________________________________ Date:_________________________

Quality Unit (QU)

Originally published in the October 2002 issue of the Journal of GXP Compliance

C o n d u c t i n g Au d i t s, G A P A s s e s s m e n t s, & C o r r e c t i ve A c t i o n s 51