SOP for Document Control, Issuance and Numbering System

PURPOSE

This procedure provides instructions for generating, using, and controlling all GMP-related documents.

Specific requirements for document change control are included in other documents.

SCOPE

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 covered in other documents.

RESPONSIBILITY

• 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 review and approval activities described in this procedure
• 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
• Quality Assurance (QA) – overall control of the document system, all activities relating to compliance with this procedure, and all cGMP requirements.

DEFINITIONS

• Effective Date: the date a controlled document becomes official, and must be used as the only reference for that activity
• Form: a controlled document used to convey reference information, or designed to allow the recording of data to support pharmaceutical production and related activities

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• QA-controlled document: any Standard Operating Procedure (SOP), form, or other documents subject to QA review and approval, controlled issuance, controlled change, revision control, and archive security
• Revision history: Record of all changes that have occurred to a document, and the reasons for those changes
• Standard Operating Procedure (SOP): a written document that describes activities necessary for cGMP compliance for pharmaceutical product manufacturing, packaging, testing, or distribution.

REFERENCE DOCUMENTS

• Procedures for changing documents are described in the SOP “Document Change Process.”
• Training on new or revised documents is described in SOP “Training Documentation for New or Revised Documents.

PROCEDURE FORMAT

• 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.
• All SOPs will have a standard format that includes the following components:

1. A descriptive, but not long, title
2. Final approval that includes Document Preparer, Department Approver, and QA final approval
3. Revision history – a table that includes a brief description of the changes occurring in each version, along with justification for each version change
4. Purpose – a statement on the reason for the document
5. Scope – a statement identifying any limits associated with the activities covered by the procedure.
6. Definitions – a definition for any new terms or terms requiring clarification
7. Responsibilities – a statement identifying any specific responsibilities outlined in the procedures
8. Requirements – detailed statements outlining the specific requirements or obligations included in the document.

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PROCEDURE NUMBERING SYSTEM

All SOPs and forms will comply with the following numbering system:

• The numbering system to be used is illustrated as follows: QCS – 001 – 00
• 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

• The third digit will identify the type of document.

Department Identifier	Department Name
C	Calibration
F	Form
M	Method
P	Policy
S	Specification
X	Cleaning

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

DOCUMENT ISSUANCE

• All new versions of a document will include a new version number. This includes minor changes made to correct typographical errors, etc.
• After all document approvals have been obtained on a new or revised document, the QA Document Control group will ensure that all required training has been documented. Only after verifying that training is complete, can the document be issued.
• 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 record.

• Issuance of new or revised documents will include the following steps:

1. Update the document index. The update will include adding the new document or replacing the old version from the index.
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 deactivated or removed from the active index.
3. Paper copies will be stamped with the “Official Copy” stamp. This colored ink will identify that these copies are official and active.
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 replace active files to include the new index and document.

ACCESS AND PRINTING OF DOCUMENTS

• In general, only the “official” copies of documents should be referenced. For example, only online versions of electronic documents must be referenced, and only “official” stamped paper copies should be used.
• 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 copying or printing, each document must be signed and dated by the copying/printing individual.
• Controlled copies or watermark prints are only valid for reference use and must be destroyed at the end of each working day.

DOCUMENT STORAGE AND PHYSICAL CONTROL

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

ABBREVIATIONS

QA: Quality Assurance

REVISION HISTORY

Nil

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