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What do you mean by Quality Assurance?
The sum total of the organized arrangements made with the objects of ensuring that all products are of quality required for their intended use and the quality systems are maintained.
What is Standard Operating Procedure (SOP)?
SOP is a document used for routine or repetitive administrative and technical activities to facilitate consistency in the quality and integrity of the product/activity. SOP is a written, controlled document used to describe process, procedure or practice which is required to be consistently performed.
What is the list SOPs required in QA department?
• SOP for SOP.
• SOP for format preparation.
• Change Control.
• Deviation.
• Non-conformance product.
• Market Complaints.
• Product Recalls.
• Returned Goods.
• Vendor Qualification.
• Preparation of BMR&BPR.
• Assigning of Manufacturing & Expiring date.
• Annual Product Review.
• Corrective & Preventive Action.
• Process Validation.
• Cleaning Validation.
• Equipment Qualification.
• Glossary of terms.
• Document Control.
• Review of BMR/BPR & analytical reports.
• Batch Numbering System.
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MSDS means Material Safety Data Sheet and it contains 16 contents. Those are given below:
• Product Identification.
• Composition/ Information on Ingredients.
• Hazards Identification.
• First Aid Measures.
• Fire Fighting Measures.
• Accidental Release Measures.
• Handling & Storage.
• Exposure Controls / Personal Protection.
• Physical & Chemical Properties.
• Stability & Reactivity.
• Toxicological information.
• Ecological Information.
• Disposal Consideration.
• Transport Information.
• Regulatory Information.
• Other Information.
What are the different types of Qualifications?
Qualifications are as follows:
• Design Qualification.
• Installation Qualification.
• Operational Qualification.
• Performance Qualification.
What are the different types of cleanings?
There are three types of cleanings:
• Batch to Batch Cleaning.
• Periodically Cleaning.
• Product Change over cleaning.
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• Sweetening Agents.
What are In-Process checks?
In-process checks are checks performed during an activity, In order to monitor and if necessary to adjust the process to ensure that product confirms to its specification.
What is 21 CFR part 11?
Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
What are User Requirements?
User requirements specification describes what users require from the system. User requirement specifications are written early in the validation process, typically before the system owner and end users, with input from Quality Assurance.
Requirements outlined in the URS are usually tested in the PQ. User requirements specifications are not intended to be a technical document; readers with only a general knowledge of the system should be able to understand the requirement outlined in the URS.
Why water for pharmaceutical use is always kept in close loop in continuous circulation?
Water is best medium for many microorganism can be a highly pathogenic which causes serious diseases (many disease are water born), these pathogens infect after consumption of contaminated water, microorganism tend to settle on a surface if water is allowed to stand in a stagnant position for few hours, these settled microorganism form a film over the surface of vessel and piping, such film formed by microorganisms is also called as biofilm, biofilms are very difficult of remove, once a biofilm is formed at a particular point then that point may form a biofilm again even after cleaning very easily as seed from this point is may not completely get removed effectively.
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The ratio of the actual water vapor pressure of the air to the saturated water vapor pressure of the air at the same temperature expressed as a percentage. It is the ratio of the mass of moisture in the air, relative to the mass at 100% moisture saturation, at a given temperature.
What is unidirectional airflow (UDAF)?
Unidirectional airflow should be used to provide product protection by supplying a clean air supply over the product, minimizing the ingress of contaminants from surrounding areas and also provide protection to the operator from contamination by the product.
Sampling of materials, primary packaging materials and products, should be carried out in the unidirectional airflow environmental conditions that are required for the further processing of the product in a dispensing booth situation.
Dispensing booth should be provided with unidirectional airflow for protection of the product and operator.
What is the flow direction of pressure differential in manufacturing facilities?
Manufacturing facilities should be maintained at a +ve pressure relative to the outside, to limit the ingress of contaminants.
Where facilities are to be maintained at negative pressures relative to the ambient pressure to prevent the escape of harmful products to the outside.
Negative pressure zones should, as far as possible, be encapsulated by surrounding areas with clean air supplies, so that only clean area can infiltrate into the controlled zone.
What is NDC Code (National Drug Code)?
Each listed drug product listed is assigned a unique 10 digit, 3 segment numbers. This number, known as the NDC, identifies the labeler, product and trade package size.
• The first segment the labeler code is assigned by the FDA. A labeler is any firm that manufacturers (including repackers or relabelers) or distribute (under its own name) the drug.
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The smaller items are frequently transported to a designated cleaning or washing area where the cleaning procedures is performed. This practice is known as clean-out -place (COP).
What do you mean by worst case?
A condition or set of conditions encompassing upper and lower processing limit and circumstances, within standard operating procedures, which poses the greatest chance of product or process failure when compared to ideal conditions. Such conditions do not necessarily induce product or process failure.
What is the difference between specification and Limit?
Specification
A document giving a description of a starting material, packaging material, intermediate, bulk or finished product in terms of its chemical, physical & possibly biological characteristics. A specification normally includes description clauses & numerical clauses, the latter stating standards & permitted tolerances.
Or
Lists of detailed requirements with which the products/ materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation.
Limit
The point, edge or lines beyond which something cannot or may not be proceed. The boundary surrounding a specific area, bounds.
What are the advantages of Swab sampling?
• Dissolves & physically removes sample.
• Adaptable to a wide variety of surfaces.
• Economical & widely available.
• May allow sampling of a defined area.
• Applicable to active, microbial & cleaning agent residues.
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The degree of drying is dependent on,
• Temperature
• Drying time
LOD or water content of pharmaceutical products can include both bound (e.g. water of hydration) and free water. In case there are additional traces of other volatile impurities present, like alcohol: LOD ma be higher than water content. In other cases, LOD may be lower than water content, as bound crystal water may not be removed by heating
%LOD = %water content - %Water molecule in API
What is Commissioning?
Commissioning is the documented process of verifying that the equipment and systems are installed according to specifications, placing the equipment into active service and verifying its proper action. Commissioning takes place at the conclusion of project construction but prior to validation.
What is Design condition?
Design condition relates to the specified range or accuracy of a controlled variable used by the designer as a basis for determining the performance requirements of an engineered system.
What is Operating range?
Operating range is the range of validated critical parameters within which acceptable products can be manufactured.
What is Turbulent flow?
Turbulent flow, or non-unidirectional airflow, is air distribution that is introduced into the controlled space and then mixes with room air by means of induction.
What is pressure cascade?
A process whereby air flows from one area, which is maintained at a higherpressure, to another area at a lower pressure.
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“As the Pharmaceutical Industry is an “OCEAN” so it’s impossible to cover all the topics in a single Hand Book. That’s why this QA HAND BOOK is considered as Edition-I. In future I will again write a QA HAND BOOK which will be Edition-II”.