SOP On SOP – Initiation of new SOP In the Pharma Industry
To lay down Standard Operating Procedures for Preparation, Checking, Approval, Issuance, Review, Retrieval, Storage, and Destruction of Documents.
SCOPE :
This SOP applies to all Non-Batch Related Documents of Various Departments.
RESPONSIBILITY
Concerned Department personnel are responsible for Document Preparation.
Officers / Executives / Managers are responsible for the Review / Checking of the prepared Documents.
The head QA is responsible for the Approval of Reviewed / Checked Documents.
The Plant Head is responsible for the Authorisation of Approved Documents.
Officer QA is responsible for the Issuance of Documents.
All Heads of the Departments are responsible for the Implementation of this SOP.
Head Quality Assurance is responsible for overall compliance with the SOP.
DESCRIPTION OF DOCUMENTS
The documents are classified into Two Categories, Batch Related Documents, and Non-batch Related Documents. Similarly, they are classified as Instructions in the form of Standard Operating Procedures and the documents that require entries for maintaining the related data. These documents which record data comprise protocols, registers, and recording forms.
The Batch related documents contain the following documents, Documents not requiring data entry or recording or Instructional documents-
- Master Formula Card
- Master Packing Card
- Analytical Specifications
- Standard Analytical Procedures
Documents Requiring data entry or recording –
- Batch Manufacturing Record
- Batch Packing Records
- Analytical Protocols
- Distribution Records
(Please note that the list is not exhaustive. The additional documents may be included depending upon the specific regulatory requirements.)
The following are some of the important documents which are not attached to the Batch Documents:
Manufacturing
- Standard Operating Procedures
- Records / Logbooks related to operation and Cleaning
- Environmental Monitoring Records
- Training Records
Quality Assurance
- Standard Operating Procedures
- Qualification and Validation Documents
- Change Control Documents
- Failure Investigation Records
- Deviation Records
- Pharmaceutical Technical Complaint Records
- Technical Contracts
- Annual Product Reviews
- Self Inspection Records
- Training Records
Quality Control
- Standard Operating Procedures
- Records / Log books related to Analysis
- Records related to Microbiological Limit Testing
- Stability Study
- Microbiological Records of Monitoring of Water System & Environment
- Training Records
Engineering & Maintenance
- Standard Operating Procedures
- Records related to maintenance of Equipments
- Preventive Maintenance Schedules
- Instruments Calibration Schedules
- Training Records
Warehouse
- Stock records of RM / PM / FG
- Monitoring of Storage Room Conditions
- Rejected RM/PM Disposal / Destruction Records
- Distribution Records of Finished Goods
- Training records
SILDENAFIL CITRATE TABLETS
PROCEDURE: Preparation
The SOPs shall be prepared in all departments as per this SOP.
The BMRs shall be prepared by the Respective Department at the location as per SOP.
The Validation and Qualification protocols shall be prepared as per specified in the Validation Master Plan.
Analytical Protocols, formats, and other documents shall be prepared based on the requirements as per their respective SOPs.
Checking
The SOPs are reviewed by the concerned department head or the person in charge of the activity.
Batch Manufacturing Records shall be reviewed by Formulation and Development.
The Validation and Qualification protocols are reviewed by the validation Team Members comprising of the senior management team for correctness and appropriateness.
These documents are reviewed twice – before approving the protocol for use and after execution and report preparation.
The post-approval review is done by the project team members along with the Validation team members.
Analytical protocols, formats, and other documents shall be reviewed for their correctness and authentication by the concerned department head or the person in charge of the activity.
Approval
The SOPs shall be approved by the Head of Quality Assurance on behalf of the organizational / customer quality compliance.
The SOPs shall be authorized by the Plant Head.
The Batch Manufacturing records shall be approved by the site Head of Quality Assurance.
The BMRs shall be authorized by the Plant Head.
The validation and Qualification protocols are approved twice – before approving the protocol for use and after execution and report preparation.
The post-approval review is done by the project team members along with the Validation team members.
Analytical protocols, formats, and other documents shall be approved by the Head of Quality Assurance.
Such documents shall have provision for Pre-approval for use consisting of Prepared By, Checked By, and Approved By.
Issuance
After approval, all the documents shall be submitted to QA
Arrange for the Xerox copies of the documents as per the requirement and check their legibility and completeness.
Issuance of SOPs
Put the “CONTROLLED WHEN IN RED “Stamp on each page of the Xerox copy in Red Ink.
Put the Copy Number with a Red Pen in the space provided and as per the distribution copy list mentioned on the documents.
Make appropriate entries in the “Document Distribution and Control record” as per Annexure I and issue to the concerned departments after and get the receipt.
Issuance of Protocols / Formats
One printout of each Analytical Protocol shall be treated as a “Master Copy” and shall remain in the custody of Head QA.
Put the “MASTER COPY” stamp in red ink on each page of this printout and get a signature from the Head / In charge QA.
Arrange for the photocopy of the Master Copy of the protocols as per the requirement and check it for its legibility and completeness.
Put a circular blue colored stamp on each page stating “Indoco Remedies Ltd.” on the upper side and “Quality Assurance” on the lower side.
Sign with the date in the blank space of the stamp and allocate the running copy number with red ink.
Formats of Quality system SOP i.e. Change control protocol, Deviation Investigation, and approval form, Corrective and preventive actions review and approval form, OOS Investigation Report, Checklist for phase-I Investigation, Checklist for phase-II Investigation, and Handling of the complaint having their serial no. as per QS SOP’s, hence separate copy no. is not required for these documents.
Make required entries in the respective logbook, get receiving from the concerned person, and handover it to him/her.
To issue formats, make required entries in the logbook as per Annexure III, get receiving from the concerned person, and hand over it to him/her.
Issuance of Log Books and Formatted Log Books
The size, shape, and binding properties of the log books should be finalized before printing.
Control the log book by affixing the “Log Book Issuance” label on the Cover Page of the Log Book.
Put the entries in the Logbook label and record the issuance entries in the issuance register as per Annexure IV.
Record the Issuance of Formatted Log Books in the issuance register.
Review
The documents will be changed after the completion of their review period or as per requirements for system gradation.
Whenever applicable, documents shall be changed by mentioning the reason for the change and the change in version number.
For each change of the document, the details of the document superseded by new documents are mentioned in the new document.
Retrieval
All the control copies of the obsolete documents are retrieved at the effective date of revised versions ensuring that all the copies of the old documents are retrieved as per the distribution list.
The master copies of the obsolete documents are retained in a separate file by stamping them as “OBSOLETE” with red ink.
Logbooks shall be retrieved at the time of issuance of new ones.
Storage
All Batch-related documents, documents related to Qualification & Validation as well as other QA / QC documents are stored safely and securely in the custody of Quality Assurance.
The Batch Related Documents shall be stored for a period of a minimum of 1 year from the date of the expiry of the products. The retention period may vary in case of customer requirements (if any).
The other documents about QA / QC / Production / Warehouse / Engineering shall be retained for a period of a minimum of 7 years after the date of generation of the documents.
The Qualification and Validation documents shall be stored for the life of the plant/machinery.
The documents related to process validation shall be stored for 20 years after the life of the product.
The training records shall be stored for 3 years after retirement or the date of leaving the company.
Destruction
Control copies of the SOPs, master lists, and schedules will be destroyed at the time of issuance of their new version.
After completion of the storage period of documents, ensure that there is no issue pending related to the documents.
Enter the details of documents to be destroyed in “Request Form for Document Destruction” as per Annexure V and get approval from the Head QA and Plant head.
After approval, tear the documents into small pieces and send them to Scrap Yard for final shredding.