SOP For format issuance and control 

• OBJECTIVE
  • To lay down the Procedure for format issuance and control.
• SCOPE
• RESPONSIBILITY
  • Executive-Quality Assurance
• ACCOUNTABILITY
  • Manager-Quality Assurance.

PROCEDURE

• DOCUMENT CONTROL & ISSUANCE
  • All formats originating from the SOPs shall be taken on a stand This SOP is applicable for all departments to control documents, which are Approved and Issued by Quality Assurance Department at Pharmaceutical Company and A4 size paper and stamped as “Master Copy” in blue ink on top left corner of all the pages.
  • QA shall make Master formats file Department wise with index as per format no. SOP/QAD-002/FT01-00.
  • All Master formats shall be archived in Quality Assurance Department.
• ISSUANCE OF FORMATS
  • QA shall record the issuance of format in issuance record.
  • Loose format in case of BMR/ BPR shall be stamped with “Controlled Copy” stamp, with initial of QA Personnel and Date.
  • Loose formats other than BMR/BPR and analytical test data sheets shall be either bound book or spiraled are numbered serially and maintained by the respective department for execution.

• ARCHIVAL OF DOCUMENTS
  • QA Department shall archive the executed records Department wise and Year wise in document storage room.

• REVISION OF DOCUMENTS
  • Format shall be revised as when it is needed. Format revision shall be controlled through Change Control Procedure.
  • QA shall ensure the revision control as follows:
  • All previous formats shall be retrieved from the place of operation after keeping new version  in place.
  • Original version of written procedure shall be stamped as ‘OBSOLETE COPY’ in Red color at the bottom Center of each page of the format and archived along with Change Control form in Quality Assurance Department.
  • Previous version of all controlled photocopies shall be retrieved and destroyed.

• DESTRUCTION OF DOCUMENTS
  • Executed documents shall be destroyed by shredding or by incineration after 1 year of product expiry date.
  • The following documents shall not be destroyed.
    • Obsolete and current documents.
    • Validation protocols and reports.
  • All Controlled copies shall be destroyed, after the Master Copy is OBSOLETE.
• ABBREVIATIONS
• BMR –  Batch Manufacturing Record
• BPR –  Batch Packaging Record  

• Attachments:

• DISTRIBUTION LIST

 REVISION HISTORY       

                                                               Attachment -1

                                                       MASTER FORMAT INDEX

Department: …………………….

Prepared By                                                                                                               Approved By                                           

Sign/ Date:___________________                                  Sign/ Date:_______________                  

                  (Executive – QA)                                                                                                  (Manager-QA)                               

                                               Attachment -II

                FORMAT REQUISITION AND ISSUANCE RECORD

To         : QA Department            Date: ____                                                                                                                                            

From    : __________________________Department

                                                     Attachment -III

LOG BOOK REQUISITION, ISSUANCE AND RETRIEVAL RECORD

SOP For Procedure For change control system