SOP .in



1. Objective

To define the procedure for the preparation, control, and retention of GMP relevant documents.

2. Scope

This standard operating procedure (SOP) is applicable for all departments of Solitaire Pharmacia Pvt. Ltd., Baddi that are concerned with document as defined below-

Document-: The word “Document” shall cover standard information, instruction and records concerning facilities, material, manufacturing process or systems that are established in Solitaire Pharmacia Pvt. Ltd., Baddi and have good manufacturing practice (GMP) impact directly or indirectly, for example-:

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Information

Site master plan

Drawing

Specification

Instructions

Standard Testing procedure(STP)

Protocols

Records

Batch manufacturing record

Completed forms, etc.

3. Responsibility

All employees of Solitaire Pharmacia Pvt. Ltd., Baddi who create, revise, check and approve the document are responsible for adhering to the content described in this SOP.

Quality Assurance is responsible for assuring the appropriate control over document such as distribution, change, retention and destruction of the document.

4. Accountability

Head QA

5. Procedure

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1. Document Preparation

1. The documents mentioned in section 2.0, can be written by any trained personnel of the concerned department.

2. All the documents have to be prepared or written in general English/Local language (If applicable)

3. Once the document is drafted, it is to be reviewed for its applicability, completeness and correctness by a reviewing authority.

4. After reviewing and signing, the document shall be handed over to “Quality Assurance Department” (QA) for approval.

5. Q.A Head shall review the document for its compliance with cGMP/Regulatory requirement/In-House quality systems and approve the document.

6. The approved copy of the document shall be sent to the Head of the concerned department, /Training coordinator for carrying out the training (if require).

7. After the completion of the training or other action (if any), QA department will write the effective date and next review date on the original document. The date will either be printed on the document or else it would be manually written.

2. Document Control

1. All the document shall be controlled and distributed by the Q.A department.

2. Master copy of document shall be stamp at the bottom right corners of each page as “MASTER COPY” in red stamp.

5.2.3 The copies of the document, which are meant for the use, are to be stamped as “CONTROLLED COPY” in blue. Controlled copy shall not be further photocopied.

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4. The copies of the document, which are meant for reference, only are to be stamped as “UNCONTROLLED COPY” in red.

5. New document shall be distributed on current version of format no. SPL/QA/002.

6. Withdrawal of any document shall be done as per current version of format no. SPL/QA/005.

7. Quality assurance shall retrieve the control copy of documents. All retrieved obsolete controlled document shall be destroyed by Q.A and the obsolete master copies shall be stamped with OBSOLETE in Red stamp on each page.

8. In case of revision of document, Quality assurance shall retrieve the superseded documents. All the retrieved superseded controlled document shall be destroyed by Q.A and the superseded master copies shall be stamped with SUPERSEEDED in Red stamp on each page.

9. All the SOPs are control, distributed, retrieve and destructed as per SOP no.”SPL/SOP/QA/001”

10. The record shall be maintained by Q.A department for distribution, retrieval and destruction of document as per format no. SPL/QA/003.

11. Formats & Logbooks shall be issued as per current version of format no “SPL/QA/008” (Formats /Logbooks Issuance Record).

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1 All formats and logbooks shall be a part of SOP.

2 The master copy of all the formats and logbooks shall be maintained by QA department.

3 The quality assurance department shall issue the control copy of formats and logbooks to all concern departments as per Format no SPL/QA/008.

4 Using control copy as a reference the concern department may print the formats and logbooks in the form of books/pads in A4 size paper as per their requirement and will take approval from QA.

5 Each book / pad shall contain 100 formats or logbooks or as per requirement.

6 The formats and logbooks shall be issued by QA department by maintaining format control log book as per Format no SPL/QA/008.

7 The log book details shall be stamped on the cover page of the all issued formats and logbooks books/pads.

8 Note :

In case if the printed formats and logbooks are not available then QA will issue the control copy of required format and logbook to user department.

10 Photocopy of control copy is not allowed.

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11 Document Retention

1. All the documents (process validation reports, production records Qualification records like DQ, IQ, OQ and PQ, training records distribution records etc.) shall be retained as per the following table (Table-1)

Table -1

|S. No. |Description of the document |Retention Period |

| |Equipment History sheets |Life Cycle +1 year |

| |Calibration Records |Life Cycle +1 year |

| |Preventive Maintenance Records |5 years |

| |Formats & Logbooks |5 years |

|Warehouse Records: |

| |Stock records |5 years |

| |Distribution Records |5 years |

|Validation Reports: |

| |Development Reports |For ever |

| |Technology Transfer documents |For ever |

|Training Records: |

| |All Training Records |Till employees is with company +5 year |

|Supporting systems: |

| |Utilities documentation |Life Cycle +1 year |

|Production; |

| |Batch Manufacturing Records |Shelf life of Batch +1 year |

| |Equipment Cleaning Records |5 years |

| |Formats & Logbooks |5 years |

|Quality Control: | |

| |Qualification Records (IQ, OQ and PQ) | Life Cycle+1year |

| |Testing Records (Batch Analytical Report) |Shelf life of Batch+1 year |

| |Calibration Records |5 years |

| |Analytical Method Validation |Life Cycle +1 year |

| |Formats & Logbooks |5 years |

|Quality Assurance Records |

| |Change Control Records |5 years |

| |Deviations Records |5 years |

| |OOS Records |5 years |

| |Market Complaint Records, Product Recall Records |5 years |

| |Vendor Records |5 years |

| |Master Formula Records |For ever |

| |Master-Equipment Cleaning Records |Life Cycle +1 year |

| |Superseded - Standard Operating Procedure |5 years |

| |Superseded - Standard Testing Procedure/ Specification |5 years |

| |All Validation Records |Life Cycle +1 year |

| |Formats & Logbooks |5 years |

| |Report of Internal Audit |5 years |

| |External customer Audit |5 years |

| |Report of Regulatory Audit |For ever |

|HR Records |

| |Medical Checkup Records |Till employees is with company +5year |

| |Employees Records (Job Responsibility, Signature specimen log) |Till employees is with company +5 year |

|Engineering Records: |

| |Qualification Records (IQ, OQ and PQ) |life cycle + 1 years |

5.3.1.1 Note-LC means “Life cycle” of the product where shelf life is included.”Life cycle” means the process staring with the user requirements, continues through design, qualification, process validation and maintenance until the status label of “NOT IN USE”.

5.3.2 Document after the retention period should be destroyed either by burning or by shredding.

5.3.3 Documents that shall be destroyed after the retention period is over shall be listed and permission shall be taken from Head-QA & record maintain per current format SPL/QA/003.

6. Records/Formats

SPL/QA/008 - Formats /Logbook Issuance Record

7. Annexure

NA

8. Reference

ICH Guideline -Q7

9. Abbreviations

SPL - Solitaire Pharmacia Pvt. Ltd., Baddi.

QA - Quality Assurance

ICH - International Conference on Harmonization

SOP - Standard Operating Procedure

STP - Standard Testing Procedure

DQ - Design Qualification

IQ - Installation Qualification

OQ - Operational Qualification

PQ - Performance Qualification

LC - Life Cycle

10. Revision History

|Revision No. |Effective Date |Reason for Revision |

|00 | |New Document |

Format /Logbook Issuance Record

Format No. SPL/QA/008

Format No. |No. of Formats and logbooks /Books/Pads Issued |Department |Date of Issue |Total Pages |Issued By |Issued To |Retrieved on (Date) |Retrieved

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SOP. No. : SPL/ SOP/QA/002

Page No. : 6 of 6

Supersedes : New

Revision No. : 00

Effective Date Review Date

Title: Document Preparation, Control and Retention

Prepared By Checked By Reviewed By Approved By Concerned Dept Concerned Dept QA QA-Head

STANDARD OPERATING PROCEDURE

Title: Document Preparation, Control and Retention

Prepared By Checked By Reviewed By Approved By Concerned Dept Concerned Dept QA QA-Head

SOP. No. : SPL/ SOP/QA/002

STANDARD OPERATING PROCEDURE

RESTRICTED CIRCULATION AUTHORISED PERSONS ONLY

RESTRICTED CIRCULATION AUTHORISED PERSONS ONLY

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