10 Questions
The next review date for the SOP is on 01-09-2021.
False
The SOP for Change Control System is designated as SOP/QAD/005-00.
True
The 'Justification for Change' section may include reasons like GMP requirements.
True
The SOP was approved by the Asst. Manager Q.A, Govind Singh.
False
According to the document, the 'Impact Analysis' section should cover impacts on Product, Process, and Personnel.
False
The SOP is designated as SOP/QAD/006-00.
True
The effective date of the SOP is 01-10-2020.
False
Quality Assurance is responsible for the issuance, impact analysis, review, and implementation and closing of the deviation.
True
The SOP covers handling deviations in Yield and Equipment but not in Procedures.
False
The next review date for the SOP is set for 31-08-2022.
True
Study Notes
SOP for Change Control System
Department and Title
- Quality Assurance department
- SOP for Change Control System
SOP Details
- SOP No.: SOP/QAD/005-00
- Revision No.: 00
- Supersedes No.: N/A
- Effective Date: 01-09-2020
- Next Review Date: 31-08-2022
Scope of Change Control
- Describes department, equipment, document, process name, and scope of change
- Example: revising document Number XXX to incorporate test from current pharmacopoeia
Justification for Change
- Explains reason for change
- Includes implications for other changes, GMP requirements, regulatory changes, equipment additions/deletions, and process/test method/protocol changes
Existing Procedure/Equipment/Facility/Document
- Briefly describes existing process/facility/procedures in documents to be changed
Proposed Change
- Describes changes proposed correlating with existing system, document
Impact Analysis
- Analyzes impact on product, process, stability
Approval and Review
- Prepared by: Uncing Melkwunce (Officer Q.A.)
- Reviewed by: Govind singh (Asst.Manager Q.A)
- Approved by: Pavan Mishra (Quality Head)
- Dates: 17-08-2020, 18-08-2020, 29-08-2020
Deviation Management Standard Operating Procedure (SOP)
Overview
- The SOP is for identifying, investigating, documenting, reviewing, and resolving deviations in Towa Pharma.
- Effective date: 01-09-2020; Next review date: 31-08-2022.
Scope
- Applicable to handling deviations in process parameters, yield, equipment, facility, procedure, and system in all areas of Towa Pharma.
Responsibility
- Initiator department: reports, initiates, and ensures compliance with deviations, provides justification, recommendations, and Corrective and Preventive Actions (CAPA).
- Quality Assurance: issues, analyzes, reviews, and implements deviations.
- Initiator department head: investigates, identifies root cause, reviews CAPA, and ensures deviation compliance.
- Head QA: approves or rejects and closes deviations.
Function
- Prepared by: Umang Makucina, Officer Q.A.
- Reviewed by: Govind Singh, Asst. Manager - Q.A.
- Approved by: Pavan Mishra, Quality Head.
Document Control
- SOP No: SOP/QAD/006-00
- Revision No: 00
- Supersedes No: N/A
- Format No: F-SOP/QAD/001-01/00
- Display Copy for restricted circulation only.
This quiz is about the Standard Operating Procedure (SOP) for the Change Control System in the Quality Assurance department, covering scope, justification, and implementation of changes.
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