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SOP on Document Management System in Quality Assurance Department.

Objective:

To lay down a procedure for the Management of Documents in the Quality Assurance Department.

Scope:

Applicable for Document Management system in Quality Assurance department.

Responsibility:

Quality Assurance Department

Accountability:

Manager Q.A. is accountable for the compliance of this SOP.

Procedure:

Storage of Documents in Record Room.

Documents shall be stored in the record room compactor.

The Record room contains 8 Compactors which have been marked as C1 to C8. Each compactor has 20 racks, except Compactor number 1 and compactor number 8, which contains 10 racks each.

The Racks have been given the rack number of 5 digits for example in Rack number “C2 R15” the first two digits “C2” represent the Compactor number 2 and the last two digits represent the rack 15 in the compactor.

The document which is to be stored in the compactor shall be checked and verified by the QA officer or above.

The document will be assigned to a particular Rack in a particular Compactor.

The Master List of documents that are kept in the compactor will be maintained by the  QA as per the

Index for each compactor shall be maintained as per the Annexure. Copy of Annexure shall be pasted on each compactor

Master List and the Annexure will be updated immediately after the addition or removal of documents from the compactor.

In case any document is required, the same shall be issued and recorded as per the annexure.

Document Management

 Storage of Documents in QA Department.

All the documents which have been approved and mastered shall be kept under lock and key and shall only be accessible to the authorized personnel of QA.

Documents shall be kept in the files having the file number starting from 01 onwards as the sequences increases.

All the files except the files containing STPs / GTPs / Specification / SOPs must have the Index on the first page of the file as per the format.

Files containing the documents can be kept in the 6 Almirah which has been numbered from A1 to A6 and the shelf shall be labeled as S1, S2, S3 …..onwards.

Index for the documents in each Almirah shall be pasted on the backside of the door of Almirah mentioning the file number and the shelf number as per the.

Master List of all the documents shall be maintained as per format master list of documents shall be updated quarterly and in between changes can be done manually on the master list.

No document shall be kept without file and no master document shall be kept in the personal drawers for any reason.

Issuance of Master and other documents for reference purposes.

Documents shall be issued for reference purposes as per

Storage of other Documents and samples in the QA Department.

Other things like COAs, Logbooks, worksheets, reference samples, party samples, stationery can be kept in the Racks without locks numbered as R01 to R14.

Every rack shall be dedicated to only one type of item only.

The rack shall be labeled with the name of the items on it.

The list of items and the control of items can be maintained in the in-house format.

List of Annexure / Formats:

S. No. Format Title Format

Number

Annexure

Number

No. of Pages
1 Master List of Documents
2 Index of Documents
3 Documents Issuance record
4 File Index
5 Almirah  Index

 

 References (If any): NA

 Reason for Revision:

Not applicable.

 Abbreviation & Definition:

QA:       Quality Assurance

SOP:      Standard Operating Procedure

STPs:      Standard Test Procedure

GTPs:     General Test Procedure

END OF SOP

S. No Date Document(Details) File No. Location Submitted By Kept By

MASTER LIST OF DOCUMENTS

INDEX  

COMPACTOR NO.
 
DOCUMENTS DOCUMENTS
C1 R01 C1 R06
C1 R02 C1 R07
C1 R03 C1 R08
C1 R04 C1 R09

 

S. No Date Document Location Issued to Issued by Purpose of Issuance Returned On Checked by

DOCUMENTS ISSUANCE RECORD

FILE INDEX 

FILE NAME : 

FILE NO : 

S No Document/Product name Document Number Effective date
       

ALMIRAH INDEX

ALMIRAH NO.:

S NO. DOCUMENT FILE NO. SHELF NO.

 

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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