SOP on issuance, retrieval and archival of formats and logbooks

Purpose
To describe the procedure for issuance, retrieval and archival of formats and logbooks.

Scope

This procedure is applicable for issuance, retrieval and archival of formats and logbooks used for the recording, monitoring and execution of daily or routine operation to all functions ABC Limited.

Procedure:

• Executive/Officer/Designee of concern department shall identify the formats/logbooks to be used within the department and shall raise document requisition
• Executive/Officer/Designee of concern department shall send dully filled & signed requisition, reviewed by In-charge of concern department for the upcoming month in the last week of current month to Quality Assurance.
• Photocopy of format/logbook issuance shall be issued to all concern department for use.

Issuance of Formats:

• Executive/Officer of concern department shall send duly signed and reviewed request of format to Quality Assurance department. Executive/Officer-QAD shall photocopy required number of copies from master copy on A4 size white paper.
• Executive/Officer/Designee-QAD shall stamp “CONTROLLED & ISSUED by embossed with sign and date” at right corner of the header part of first page of formats in red color ink along with signature and date. Second page onwards of format, Executive/Designee-QAD shall stamp “CONTROL COPY” at right corner of the header part in red colour ink without sign and date.
• Executive/Officer/Designee-QAD shall maintain separate logbooks for issuance of formats department wise.
• Concern department shall maintain all the issued formats within the department.
• If any format not used by any reason, such format shall return back to Quality Assurance.
• All the filled formats of current month shall be submitted to QAD in first week of upcoming month.

Issuance of equipment/instrument and other usage logbooks:

• Executive/Officer of concern department shall send duly signed and reviewed request of logbook to Quality Assurance department two day prior to requirement
• Before issuance of new logbook, Executive/Designee-QAD shall retrieve previously issued old logbook from the concern department.
• On the receipt of request, Executive/Officer/Designee-QAD shall write page numbering on right corner at the header part on each pages of logbook if not pre-printed.
• Equipment/Instrument/system and other usage logbook shall be issued by Executive/Officer/Designee-QAD after certification
• Orientation of Certificate may be portrait or landscape.
• Logbook shall be controlled /stamped as following:
•  Executive/Designee-QAD shall stamp “Quality Assurance” in blue ink along with sign and date at the right bottom of Certification page.
•  If any logbook binds internally, Executive/Officer/Designee-QAD shall stamp “Quality Assurance” on all pages including Certification page while printed logbooks from outside shall be stamped on Certification page only.
• Executive/Officer/Designee-QAD shall allot logbook numbering
• After numbering, Executive/Officer/Designee-QAD shall record the issuance activity in the logbook issuance record as per Format No.: PAL/QAD/002/F/04 (current version).
• Logbook shall not contain “Effective Date, Prepared By (Sign. & Date), Checked By (Sign. & Date) & Approved By (Sign. & Date)” which are bind from vendor while logbooks which are bind internally shall contain the “Effective Date, Prepared By (Sign. & Date), Checked By (Sign. & Date) & Approved By (Sign. & Date)” respectively.
• All retrieved records shall be maintained as per their retention period described in SOP “DOCUMENT & DATA CONTROL”.
•  Issuance of Test Data Sheet:
• Based on the batch manufacturing and batch packing record, Executive/Officer-QAD shall photocopy required number of copies of test data sheet from the Master TDS of in-process and finished products.
• Executive/Officer/Designee-QAD shall stamp “CONTROLLED & ISSUED by embossed with sign and date” at right corner of the header part of first page of TDS in red color ink along with signature and date.
• Second page onwards of TDS, Executive/Officer/Designee-QAD shall stamp “CONTROLLED COPY” at right corner of the header part in red color ink without sign and date.
• Executive/Officer/Designee-QAD shall enclose the TDS with respective batch manufacturing and batch packing record and issued to production person at the issuing of respective batch card.
• Executive/Officer/Designee-IPQA shall submit the TDS along with in-process or finished product samples to Quality Control respectively.
• In case of raw and packing material TDS, Executive/Officer/Designee-QCD shall send the dully filled & signed requisition for TDS Executive/Officer/Designee-QAD shall maintain separate TDS issuance record for each dosage form, raw material & packing material.
• Raw material and packing material test data sheet shall be retained by Quality Control department.
• In process and finished product TDS shall be enclosed with respective batch manufacturing and packing record.
• The retention period of all the records shall be as per SOP “DOCUMENT & DATA CONTROL”.