SOP for Document distribution, Control, Storage and Disposal procedure

PURPOSE

To lay down a procedure for document and data control to ensure uniformity of the available documentation throughout the organization for proper implementation of Quality Systems.

SCOPE

To prevent unauthorized changes made to documents prepared at Pharmainfo Ltd. To lay down and to follow practice respectively with GMP.

RESPONSIBILITY

QA Chemist / QA Officer

ACCOUNTABILITY

Head Quality Assurance

PROCEDURE

• Documents shall be regarded as legally authentic data of XYZ Ltd and shall be controlled accordingly. It is an important component of a company’s quality system.
• All practices which are followed up shall be documented as per the requirement of GMP. Any changes made in the document should be done by a person who is well familiar with the department and experienced.

• Documents for new products/processes should be prepared by the concerned department.
• When the new or modified Specification / Master Formula Record / Batch Processing Record / Manual/Protocol is prepared, it should be checked by the Head of the respective department. The identified document as mentioned in scope should be checked If there is any correction, correct it and get the approval from Q. A. Head.
• After identifying the location of the document, the document is entered into the distribution database Each document should be controlled and issued by the Q.A Dept.
• Each document should have three copies, one Master Copy which is stamped “MASTER COPY’ with green ink. This indicates that they are an official, controlled version of the document.
• The second is a controlled copy which is stamped with a controlled copy with blue ink on the front side of the page.
• Third Uncontrolled copies shall be issued for the following purpose only.

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• Each page of the document should bear the name and address of the company, the name of the document, effective date, revision status, page no, and the total no. of pages, prepared by, checked by, approved by & authorized by.
• Each document is prepared using white colored A4 paper and text in “Times New Roman’ and in ‘Regular’ font style.
• “Controlled” Document: The documents that are distributed to all concerned departments for implementation of the system and undergo revisions or updating continuously shall be made as a controlled document. This shall ensure that only current copies are in use and obsolete copies are retrieved. The following document shall be distributed as a controlled copy.
• General test procedures / Standard Packing Instruction / Bill of Material, Raw Material Specifications, Packing Material Specifications, Batch Processing record.
• Log books for equipment shall be controlled by the Q.A. department by pasting the mention below on the label Front page of the log book. The label shall contain the following details.

• Controlled copies shall be prepared by photocopying from the master copy of the document.
• Every page of the controlled document shall have the stamp of “Controlled Copy” in blue ink.
• In case of, Specification(s) received from QC Dept. Photocopy of Specification(s) shall be controlled by putting the stamp– CONTROLLED COPY” in Blue color at each page.
• Qualification Protocols (DQ, IQ, OQ, PQ) and Validation Protocols shall be used in original and after execution submitted to QA.

Document / Data approval and issue

• Each document or data shall be verified/checked for its approval and authorization prior to its control issue. The controlled circulation list of each Controlled document shall be maintained by the Quality Assurance Department as per Annexure I.
• For this purpose, a record shall be maintained to indicate the distribution status of current documents and the retrieval status of obsolete documents by the Quality Assurance Department as per Annexure-II.
• Availability of appropriate controlled documents shall be ensured by the Quality Assurance Department.
• SOP(s) and specification (s) shall be issued by Officer - Quality or his Authorized nominee.
• In case of SOP(s) & Specification(s) prepared by concerned Deptt. required Copy(s) shall be prepared by photocopying of master copy & putting the number serially with the blue ink required for distribution. Make an entry for distribution in the register as per the specified format.
• Specification(s) received from QC shall be issued, as controlled copies shall be entered in the register as per the specified format.

Document and Data changes pertaining to production, process, and Control procedures

• These changes shall be implemented through a ‘Change Control System’
• Changes to the document and data shall be reviewed and approved by the change control committee as per the Standard Operating Procedure.
• Any document undergoing such revision(s) shall have a revision history Sheet attached to it. The same shall be replaced for the previous master copy. Every such change shall be duly entered in the document modification form along with the date of the change, the reason for the change, and revision no. The change will be designated as major/Minor. Record modification details as per Annexure I.
• Such revised document shall controlled as per the procedure & shall be forwarded to the controlled copy holder for the replacement of the obsolete documents.
• Such obsolete documents shall be maintained with an “OBSOLETE” stamp with a red color on it. This shall be maintained for historical purposes. (Master copies of such obsolete documents shall be maintained by QAD with the “OBSOLETE” stamp marked on it). “Obsolete” documents shall be stored separately from current documents
• All other retrieved controlled copies of obsolete documents shall be destroyed by tearing off or by incineration process.

Storage document

• All documents related to batch manufacturing, analysis, training a quality management system shall be retained for a minimum period of 5 years (unless investigation is completed) in quality assurance custody.

ABBREVIATIONS

SOP: Standard Operating Procedure

QA: Quality Assurance

QC: Quality Control

GMP: Good Manufacturing Practices

ANNEXURES

Annexure I - Modification History Sheet

Annexure II - Document Issue LogBook

REVISION HISTORY

Nil

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