Define Pharmaceutical Stating Materials, Intermediate , Bulk & Finished Products :
1. Define Stating Materials, Intermediate , Bulk & Finished Products :
Stating Materials : A starting material is known as raw material or an API. A substance is a defined quality which used in production of a pharmaceutical product & non-pharmaceutical product excluding packaging material.
Intermediate : A partly processed material that must undergo the further manufacturing steps before a bulk product.
Bulk Product : Any product that has completed all processing steps up to but not including final packaging.
Finished Products : A medicinal product, which has undergone all stages of manufacture including packaging.
Pharmaceutical Complaint, Recall, Corrective Action, Preventive Action, In-Process Control, Sanitation, Houskeeping & Self-inspection
1. Define complaint & recall.
All quality related complaints of a product from the market should be recorded & investigated accordingly to a written procedure.
Recall is the removal from the market of specified batches or all batches of a product. A recall situation can result from information entering a company in various ways:
• Customer complaints – these may be so serious as to initiate a
recall. An example could be the evidence of a lack of sterility
• GMP deviations/results of a failure investigation
• The result from the QC stability programme
• Request by the regulatory authorities
• Result of an inspection
• Known counterfeiting or tampering
• Adverse drug reaction (ADR) reported, leading to a recall decision (however, an ADR does not automatically lead to a recall).
2. Define Corrective Action & Preventive Action ?
Preventive Action : In order to prevent occurrence the potential action has to be taken from non conformity, defect or other undesirable situation.
Corrective Action : Action has to be taken to eliminate the detected non conformity or other undesirable situation.
3. What is In Process Control ? Why it is important ?
To ensure the product conformation of its specification, checking & monitoring are performed during production. The controlled of the environment or equipment may also be regarded as part of in process controlled.
Importance : It is important to adjust the process to assure that the product confirms to it final specification.
4. What is Sanitation & House keeping?
Sanitation : It is the hygienic control on manufacturing process including personnel, premises, equipment & material handling.
Housekeeping is the practice of keeping the workplace clean, tidy & free of potential hazards. Correct housekeeping is practised before, during & after the task is completed.
5. What is self inspection?
Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.
What is validation? What is the importance of validation in pharmaceutical industry?
1. What is validation? What is the importance of validation in pharmaceutical industry?
Validation is a documented evidence which provides a high degree of assurance that a specific process, method or system will consistently produce to the required specification in accordance with accepted standards of cGMP.
Importance of Validation :
a)In pharmaceutical industry the validation is required for national or international regulations
b) Validation is a part of integrated requirements of a quality system
c) Validation meets the consistency of quality product in all stages
2. What do you mean by Prospective, Retrospective and Concurrent validation?
Prospective : A prospective process validation states that three consecutive marketed batches are manufactured & tested as per prospective process validation SOP. Validation data has generated by validation committee. When all data are fully satisfied then this product are released for sale & called this process is validated to use routinely in production.
Retrospective : A retrospective process validation are performed by documenting all the historical information of existing 10 products using trend analysis data in QCMS system & its ensures that the existing process is under control.
Concurrent validation : Concurrent validation is carried out during routine production. This method is effective only if the development stages have resulted in a proper understanding of the fundamental of the process. Some manufacture refers the concurrent validation as Prospective process validation.
3. Write the basic requirements of cGMP/GLP?
Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorization or product specification.
Good Manufacturing Practice is concerned with both production and quality control. The basic requirements of GMP are that -
a. appropriately qualified and trained personnel;
b. adequate premises and space;
c. suitable equipment and services;
d. correct materials, containers and labels;
e. approved procedures and instructions;
f. suitable storage and transport;
4. What do you mean by DQ, IQ, OQ, & PQ ?
Design Qualification (DQ): documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose.
Installation Qualification (IQ): documented verification that the equipment or systems are installed or modified & comply with the approved design of the manufacturer’s recommendations and/or user requirements.
Operational Qualification (OQ): documented verification that the equipment or systems are installed or modified & perform as intended throughout the anticipated operating ranges.
Performance Qualification (PQ): documented verification that the equipment and ancillary systems are connected & can perform effectively and reproducibly based on the approved process method and specifications
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