Q. 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 the quality required for their intended use and the quality systems are maintained.


Q. What is the definition of SOP?

SOPs are detailed written instructions for the operations routinely performed in the course of any activities associated with pharmaceutical manufacturing.

A written authorized procedure which gives instructions for performing operations not necessarily specific to a given product / material, but of a more general nature the equipments preventive maintenance and cleaning; recall of products; purchasing; cleaning of premises and environmental control; sampling and inspection etc.


Q. What are the contents of the SOP?

Objective/Purpose, Scope, Responsibility, Accountability, Procedure, List of formats/Annexure, Abbreviations, Reference, Revision History.


Q. What is the list SOPs required in QA department?

SOP for SOP, SOP for format preparation, change control, deviation, Non-conformance products, market complaints, product recall, returned goods, vendor qualification, preparation of BMR & BPR, Assigning of Mfg. date & Expiry date, annual product review, corrective action & preventive action, process validation, cleaning validation, equipment qualification, glossary of terms, document control, Review of BPCR & analytical test report, batch numbering system, labeling practice, personnel training, BPCR issue and retrieval, batch release, self inspection (internal audit), file numbering system, preparation of organo-gram, preparation of COA, specimen signatures, Reprocess & rework of intermediates / API, Job responsibilities, Technology transfer, measurable quality objectives etc.


Q. Which information should master document carry on every page not just one of the pages to meet GMP?

Page number, document reference number and authorizing signatures.


Q. What is the clean room?

Clean rooms are defined as especially constructed, environmentally controlled enclosed spaces with respect to airborne particulates, temperature, humidity, air pressure, air flow patterns, air motion, vibration, noise, viable (living organisms) and lighting.

Particulate control includes:

  • Particulate & microbial contamination
  • Particulate concentration & dispersion


Q. What are the classifications of clean rooms?

Generally clean rooms are classified in to the following types as per different guidelines:

  • Schedule M: Grade A, Grade B, Grade C, Grade D
  • USFDA (US 209E): Class 1, Class 10, Class 100, Class 1000, Class 10000, Class 100,000
  • WHO 2002: Grade A, Grade B, Grade C, Grade D
  • EU GMP: Grade A, Grade B, Grade C, Grade D
  • ISO 14644-1: ISO-3, ISO-4, ISO-5, ISO-6, ISO-7, ISO-8, ISO-9
  • Australia (AS 1386): 0.035, 0.35, 3.5, 35, 350, 3500
  • Germany (VDI 2083): 1, 2, 3, 4, 5, 6

Q. What is the difference between GMP & cGMP?

  • GMP: GMP is the 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.

  • GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production.
  • Such risks are essentially of two types:
  1. Cross-contamination (in particular of unexpected contamination)
  2. Mix-ups (confusion)
  • cGMP: Current Good Manufacturing Practices. This means any procedure / system adopted by the manufacturer which proves to be necessary and important for identity, strength and purity of a product.

Q. What is the difference between Qualification and Validation?

  • Qualification is equipment / instrument oriented but validation is process oriented.


Q. What is the definition of Validation?

Validation is the documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting predetermined acceptance criteria.


Q. What are the types of validation?

Process validation, Analytical method validation, cleaning validation, facility validation, Utility validation & software validation.


Q. What is the definition of Qualification?

Qualification is the action of proving and documenting that any equipment or ancillary systems are properly installed, work correctly, actually show the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.


Q. Definition of process validation and types of process validation?

Process validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an intermediate / API meeting its pre-determined specifications and quality attributes.

Process validation is three types:

1. Prospective process validation

2. Concurrent process validation

3. Retrospective process validation


Q. What is the prospective, concurrent and retrospective validation?

Prospective process validation: Prospective Process validation shall be carried out for all the intermediate stages and Active Pharmaceutical Ingredients prior to the distribution of a new product. [ICH: GMP, EU: GMP, PIC/S: GMP]

Concurrent process validation: Any validated process undergoes a change either for the equipment or addition, deletion of a critical manufacturing process step, scale up or scale down, the same needs to be validated concurrently. This validation is carried out only after a change of an existing validated process to support the change made or involve with the requirements.

Retrospective process validation: Validation of a process for a product already in distribution based upon accumulated production, testing and control data. [ICH: GMP, EU: GMP, PIC/S: GMP]

Q. What do you mean by validation protocol and its contents of process validation?

A written plan stating, how validation will be conducted and defining acceptance criteria e.g: The protocol for manufacturing process identifies process equipments, critical process parameters, and / or operating range, product characteristics, sampling, test data to be collected, number of validations runs and acceptance test results.

Contents:
  • Protocol Approval
  • Table of contents
  • Objective
  • Scope
  • Responsibility
  • Accountability
  • Validation team
  • Brief manufacturing process (Description, Flow chart, Reaction scheme)
  • Selection of batches
  • List of equipments used in the manufacturing process
  • List of raw materials used in the manufacturing process
  • Critical operations with justification
  • In-process controls with acceptance criteria
  • Sampling & testing plan with frequency
  • Stability programm
  • Data to be complied
  • Acceptance criteria
  • Intermediate & final products quality & yield
  • Stability specification
  • Document review 
  • Training record
  • Conclusion
  • Revalidation criteria


Q. What is the definition of the procedure?

A documented description of the operation to be performed, the precautions to be taken, and measures to be applied directly or indirectly related to the manufacture of an intermediate / API (Reference: ICH Q7A).


Q. What is the master document?

Master document is a formally authorized source document relating to specifications, and / or manufacturing / analytical methods, which is protected from un-authorized access or amendment.

  • Documents required describing the quality system requirements in the organization.
  • Documents required describing the process or product characteristics.
  • Documents required by various regulatory agencies as part of compliance to GMP requirements.
  • Documents required for legal/ regulatory supports of the organization to meet the local regulations.
  • Any other documents required by government / regulatory agency.


Q. What are the types of different training programs?

1. Induction training
2. Job oriented training
3. cGMP training
4. On-going training


Q. What are the classifications of residual solvents?

Residual solvents are classified into three class based on the possible risk to human health:
  • Class-I (Solvents to be avoided)
  • Class-II (Solvents to be limited)
  • Class-III (Solvents with low toxic potential)

Q. Write the names of the different countries regulatory body.

  • United Status of America – USFDA (United state Food and Drug Administration)
  • Australia – TGA (Therapeutic Goods Administration)
  • United Kingdom – MHRA (Medicines & Health care products Regulatory Agency)
  • South Africa – MCC (Medicine Control Council)
  • Brazil – ANVISA (Brazilian Health Surveillance Agency or National Sanitary Surveillance Agency)
  • Hungary - PIC/S (Pharmaceutical Inspection Convention or Pharmaceutical Inspection Cooperation Scheme)
  • Germany – NIP (National Institute of Pharmacy)
  • Bangladesh - DGDA
  • Philippines – BFAD (Beaureu of Food & Drug)

Q. What is the abbreviation of MSDS and how many contents are mentioned & what are those?

MSDS means Material Safety Data Sheet and it contains 16 contents. Those are given below:
1. Product Identification
2. Composition / Information on Ingredients
3. Hazards identification
4. First Aid measures
5. Fire fighting measures
6. Accidental release measures
7. Handling & storage
8. Exposure controls / Personal protection
9. Physical & Chemical properties
10.Stability & Reactivity
11.Toxicological information
12.Ecological information
13.Disposal consideration
14.Transport information
15.Regulatory information
16.Other information


Q. What is the different types of Qualifications and write its flow?

Qualifications are as follows: Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification.
  • URS/DS -----FAT-----SAT-----DQ-----IQ-----OQ-----PQ

Q. What is audit/inspection and Why quality audit? Write different types of audits/inspection?

A planned and systematic examination and check of a system, procedure or operation in order  to monitor compliance with and the effectiveness of established standards and to allow for improvement and corrective measures where required.

Quality audit because of:
  • To assess the effectiveness of the quality management system
  • Assessing conformance
  • Investigating problems
  • Continual improvement of performance
  • Assessing for Registration
  • Reducing cost of operation
  • Legal requirement
    Types: 
    1. Study/test based inspection
    2. Facility based inspection
    3. Process based inspection

    Q. What are the different types of cleanings?

    There are three types of cleanings:
    • Batch to Batch cleaning
    • Periodically cleaning
    • Product change over cleaning

    Q. What is expiry date & re-test date?

    • Expiry date: The date place on the container / labels of an API designated the time during which the API is expected to remain within established shelf life specifications if stored under defined conditions and after which it should not be used.
    • Re-test date: The date when a material should be re-examined to ensure that it is still suitable for use. The period of time during which the drug substance is expected to remain within its specifications and therefore, can be used in the manufacturing of the drug product, provided that drug substance has been stored under the defined conditions.

    Q. What is deviation & its types?

    Deviation is departure from the approved instructions /established standards. There are two types of deviation and given below:
    • Controlled / planned deviation: Any deviation from documented procedure opted deliberately for temporary period to manage unavoidable situation or improving the performance of the operations, without affecting the quality & yield of drug substance and safety of the operations shall be termed as controlled / planned deviation.
    • Uncontrolled / unplanned deviation: Any deviation occurred in unplanned or uncontrolled manner such as system failure or equipment breakdown or manual error shall be termed as uncontrolled / unplanned deviation.

    Q. What is change control and its types?

    Change control is a system that control change by
    i. Identifying ownership of the change
    ii. Allowing for review and approval of the change.
    iii. Preventing changes that could adversely affect product quality or conflict with registration or regulatory requirement.
    iv. Providing an assessment of change and monitors the impact of change.

    • Level 1 (Minor): Are those that are unlikely to have any detectable impact on the quality attributes of the product.
    • Level 2 (Major): Are those that are likely to have a significant impact on the quality attributes of the product.
    The type of reasons for change control:
    - Regulatory requirement
    - GMP implementation / enhancement
    - Quality improvement
    - Capacity enhancement
    - Introduction of new product in existing facility
    - Cost reduction
    - Automation
    - Aging of facility
    - To manage the unavoidable situation
    - Market requirement

    Q. What is quarantine?

    The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection.

    Q. What is definition of critical process parameters?

    A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.

    Q. What is OOS?

    Out of Specification (OOS) results are those results, generated during testing that do not comply with the relevant specification or standards or with the defined acceptance criteria.

    Q. What is CAPA?

    CAPA is the Corrective Action & Preventive Action.
    • Corrective Action: Action taken to eliminate the causes of an existing non-conformity, defect or other undesirable situation to prevent recurrence. [Actions taken after the occurrence of a defect or problem to stop the same from recurrence].
    • Preventive Action: Action taken to eliminate the causes of potential non-conformity, defect or other undesirable situation to prevent occurrence. [Actions initiated before the occurrence of a defect or problem to prevent the same occurrence].

    Q. What is HVAC?

    The HVAC is designed to circulate the air in the area after passing it over cooling & heating coils to maintain the required environmental conditions & passing it through the series of filters to maintain desired cleanliness level in the area. The air in-take and out-take of the system is designed to maintain certain degree of pressure gradient in the area as per requirements.

    Q. How many guidelines are present in Q & what are those, describe in detail?

    In Quality (Q), total 10 guidelines are present. Those are as follows:
    1. Q1 - Stability
    2. Q2 - Analytical Method validation
    3. Q3 - Impurities
    4. Q4 - Pharmacopoeia
    5. Q5 - Biotechnological quality
    6. Q6 - Specification
    7. Q7 - Good Manufacturing Practice (GMP)
    8. Q8 - Pharmaceutical Development
    9. Q9 - Quality Risk Management
    10. Q10 - Pharmaceutical Quality System

    Q. What are the sampling techniques used in the cleaning validation?

    • Swab sampling: Areas which are reasonably accessible & hardest to clean can be evaluated, leading to level of contamination or residue per gives surface area.
    • Rinse sampling: Large areas or parts of equipments which could not be swabbed should be rinse sampled or directly extracted by solvent. Tubes, nozzles, pipes or containers with surface those are not reasonably accessible for direct surface sampling have to be rinsed with solvent.
    In addition, inaccessible areas of equipment that cannot be routinely disassembled can be evaluated.

    Q. What is OOT and define?

    “OOT” stands for Out Of Trend. It means any test results obtained for a particular batch that is markedly different the results of the batches in a series obtained using a same validated method.


    Q. What is calibration?

    The demonstration that a particular instrument or device produces results within specified limits by comparison with results produced by a reference or traceable standard over an appropriate range of measurements.

    Q. What is the micron size of HEPA filter?

    The micron size of HEPA filter is 0.3μm

    Q. What is the abbreviation of CAS Number?

    CAS Number : Chemical Abstract Service Number

    Q. What is in-process control?

    Monitoring the manufacturing process at different stages is called in-process control. In-process control of the process provides an acceptable and achievable level of built in quality assurance for the product. This is possible through appropriate GMP during all manufacturing steps.

    Q. What do you mean by market complaint?

    Any communication, written or verbal, received regarding the quality, packing directly from any traders or product manufacturer and marketing staff or any other such complaints shall be considered as a Market Complaint

    Q. Describe the categories of the market complaints?

    Market complaints are categorized into three types and are as follows:
    • Critical: Complaints related to suspected contamination, adulteration and mislabeling.
    • Major: Complaints related to the product not meeting its pre-determined critical specifications and damage to primary packaging.
    • Minor: Complaints related to the product not meeting non-critical quality attributes, or damage to secondary packaging or shortages etc.


    Q. What do you mean by re-validation?

    A repeat of the process validation to provide an assurance that changes in the process/equipments introduced in accordance with change control procedures do not adversely affect process characteristics & product quality.

    Q. What is the QMS?

    It is the quality management system to direct and control an organization with regard to quality.

    Q. What is retention sample & why retention sample is preserved?

    A part of the sample which is representative of the released batch of a finished product preserved beyond its shelf life.
    It is preserved for future reference / reanalysis in cases of market complaints or development work or any other clarification about the released batch.


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