Quality Assurance Question & Answer
1.Question: What is the SOP?
SOP is abbreviation of Standard Operating Procedure
SOP is a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
2.Question: What is the Content of SOP?
Answer: SOP content shall be divided into three parts:
- Contents of Header
- Contents of SOP Body
- Contents of Footer
All of three further have Contents:
|Contents of Header||Contents of SOP Body||Contents of Footer|
· SOP no.:
· Revision No
· Page No.
· Prepared by
· Checked by
· Approved by
· Effective Date
· Next Review Date
· Abbreviations and Definitions
· Forms and Records
|· Form number
3.Question: What is the Master Copy of SOP?
Master Copy of SOP is the original set of controlled documents or written procedures which shall be retained at Documentation Cell of Quality Assurance and shall always possess the stamp ‘MASTER COPY’ on the front side of every page.
4.Question: What is the Controlled Copy of SOP?
Controlled Copy of SOP is the photocopy of the master copy of controlled documents (like SOPs, STPs, GTPs etc.) or written procedures which shall be distributed to the user department(s) as a part of document distribution procedure and shall bear a stamp as ‘Controlled Copy. These documents are controlled documents and are retrievable whenever superseded.
5.Question: What is the Uncontrolled Copy of SOP?
Uncontrolled Copy of SOP is the photocopy of master copy of controlled documents or written procedures which shall be given to any department or person for reference purpose only. These documents are not controlled documents, hence are not retrievable
6.Question: Can defined the type of Records in QMS System?
Records can be categorized as:
Primary records (original raw data): e.g. executed Batch Records, Analytical Records, Log Books, Maintenance Records, Calibration Records, Temp-RH Records, Pressure differential records.
Secondary records/documents: these are generated as report/certificate using primary raw data.
Sundry Records / documents: These are records/documents which do not have direct affect on GMPs.
7.Question: What is the revision of document?
All the controlled documents shall be reviewed within one months before the ‘Review Date’ assigned on the concerned document.
Generally revision procedure of documents shall be of two type:
- Routine or periodic revision: Revision of document as per assigned review period of respective documents. During this review, no change required in respective document
- Provisional or conditional revision: Revision of documents before assigned review period of respective document. If need of any change observed in respective control document before assigned review period shall be initiated by only “change control.
8.Question: What is the Need to give the revision period for SOP?
Revision period for SOPs need to ensure that the policies and procedures remain current and appropriate.
Review of SOPs facilitates the updation of process and also represent whether the written procedure accurate as per your current standards or have any GAP in actual practice and need to update
For examples: The manual procedures that are replaced by the use of an automated system, changes in regulatory requirements, innovative of new procedure etc.
9.Question:What is the definition of process Validation as per USFDA Guideline “Process Validation: General Principles and Practices” January 2011 ?
Process validation: The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
10.Question: Which type of Approach is recommended for Process Validation as per USFDA Guideline “Process Validation: General Principles and Practices” January 2011 ?
The USFDA Guideline “Process Validation: General Principles and Practices” January 2011 describes process validation activities in three stages. • Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
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