The purpose of this SOP is to establish a systematic and standardized procedure SOP for Retention and Destruction of Documents within the pharmaegg.com in accordance with legal and regulatory requirements while ensuring the confidentiality, integrity, and availability of information.

PURPOSE

To define a procedure for document retention, storage, retrieval and their destruction.

1. To ensure that key documents must be retained to provide a traceable, historical record of all activities that has an impact on product quality.
2. Documentation must be readily retrievable in order to meet requirements associated with product investigations, annual product review and formal audits.
3. To define the document retention time for cGMP documentation.

SCOPE

This sop is applicable in Egg group of companies (Pvt.) Ltd. Lahore and addresses following quality related documents.

1. Batch related records.
2. Material related records.
3. Master copies of standard operating procedures.
4. Training record (Including contractual Staff), job descriptions and organogram.
5. Validation documents.
6. Facility plans, drawing and qualification reports.
7. Product specifications.
8. Audit schedules.
9. Audit reports.
10. Change control documents.
11. Annual product review reports.
12. Warehousing and distribution record.
13. SOP for Retention and Destruction of Documents

ROLE AND RESPONSIBILITIES SOP for Retention and Destruction of Documents

Role	Responsibilities
Documentation Incharge	To maintain document record of supersede documents and supervise the concerned staff to follow procedure.
QA Manager	To ensure the implementation of this SOP

PROCEDURE

Document Maintenance

1. The issuance, revision, superseding and withdrawal of all documents should be controlled with maintenance of revision histories.
2. Corrections to entries should be dated and signed and leave the original entry still readable.

Document Storage SOP for Retention and Destruction of Documents

1. Facility must have a dedicated document storage area.
2. The storage area should be kept clean and tidy.
3. The storage areas must be secured with access limited to authorized personals. If any document / dossier is required or taken out, its entry is required to be made in a register kept in storage area.
4. Whenever a document is revised, the previous version will become “superseded”.
5. The original master copy of previous version, which becomes superseded, is stamped as “SUPERSEDED” and will be retained by QA department.
6. When a document is no longer required without replacement by the next revision, it is said to be “Obsolete”.
7. The last version will be stamped “Obsolete” and will be retained by QA representative.
8. Copies of Superseded or Obsolete documents will be destroyed by the concerned section.
9. The original documents of all the departments would be kept in the custody of Quality Assurance Department.

Document Retention

1. During retention period, originals or copies of records should be readily available.
2. Specifications, instructions, procedures and records can be retained either as originals or as true copies such as photocopies or other accurate reproductions of the original records.
3. All quality related documents must be retained up to the specified period as defined in document retention period.

Document destruction

1. A list of documents should be prepared and maintained in the department to identify the obsolete / superseded record on form no. QA-F-00
2. The obsolete/ superseded documents should be timely destroyed after retaining up to the specified period, unless the retention period is formally extended by change of hold time.
3. A list of documents due to destruction should be prepared. The concerned Departmental manager will authorize for document destruction.
4. Document should be destroyed by incineration or shredding.

DOCUMENT RETENTION PERIOD

Sr. No.	Title	Retention Period	Responsibilities
01	Product Related Records: Batch related records (intermediate, bulk, filled and finished products). These records include all manufacturing records, laboratory testing, environment monitoring, production, cleaning and sanitization, equipment maintenance, equipment logbooks, stability records, process control deviation, out of specifications, complaints, recalls or other investigations.	The documents must be retained for 02 years after the expiration date of the batch of finished product. SOP for Retention and Destruction of Documents	Quality Assurance Department / engineering/ production.
02	Materials: All documentation related to raw materials, expedients, API, and packaging components including all laboratory records, OOS, deviations.	Material record must be retained for 02 year after the expiration date of the batch of finished products containing the batch of the materials.	Quality Assurance Department/ procurement/ warehouse.
03	SOPs and Methods: Master copies of standard operating procedures and operating instructions or methods.	01 year from the document superseded date or from the last time the operation was performed.	Quality Assurance Department / engineering/ production/ Stores.
04	Training records	02 years after the employment ends.	Quality Assurance Department / engineering/ production/ Stores/ HR & Admin.
05	Job Description and organization Charts	02years from the date the document superseded.	Quality Assurance Department / engineering/ production/ Stores/ HR & Admin.
06	Validation Documents Documentation related to product review (including validation master plans, validation protocols, validation reports and validation batch records) method validation, specifications and master batch records.	07 year after expiration of the last manufactured batch of finished products.	Quality Assurance Department / Validation Co-ordinator.
07	Facility plans, Drawings and Qualification Reports.	02 years from the last date facility was used.	Engineering Department/ Quality Assurance Department/ Validation co-ordinator.
08	Product specifications	05 year after expiration of the manufactured batch of finished products.	Quality Assurance Department
09	Audit Schedules For internal company and external supplier and contractors.	Audit schedules retained for 03 years.	Quality Assurance Department
10	Audit Reports Self-inspections and internal quality Audit.	Must be retained for 03 years.	Quality Assurance Department
11	Audit reports of external supplier and contractors records.	Must be retained for 03 years after all actions are completed.	Quality Assurance Department
12	Ministry of health (MOH) Audits	Must be retained for 10 years after receiving of audit reports.	Quality Assurance Department
13	Change control documentation(Product specific)	02 year after expiration of the manufactured batch of finished products.	Quality Assurance Department
14	Change Control documentation(Not product specific)Evaluation and approval records relating to changes in facilities, utilities and equipment or procedures.	Must be retained for life time.	Quality Assurance Department
15	Annual Product review Reports	01 year after expiration of the manufactured batch of finished products.	Quality Assurance Department

RELATED DOCUMENTS

SOP for Retention and Destruction of Documents

List of Supersede /obsolete documents. QA-F-00
Authorization for Destruction. QA-F-00

CHANGE HISTORY

DATE	Supersede SOP  number	CLAUSE#	CHANGE MADE
Sep 2021	—	—	This is the first version of this SOP
Sep 2023	QA-G-RDD-000 (Revision No. 00)	—	Sop revision as per sop number QA-G-GRM-000

REFERENCES

ICH Guidelines Q7, Documentation System and Specifications, Point # 6.1

DISTRIBUTION LIST

• QA Manager
• Production Manager
• Engineering Manager
• Regulatory Affairs Manager
• QC Manager
• Warehouse Manager
• Procurement Manager