Pharmaceutical Quality Compliance Interview Questions and Answers
Quality is the prime concern of a pharma company. Here we have mentioned a list of common interview questions and answers on quality compliance:
Q. What is Quality Compliance in Pharma Sector?
Pharmaceutical quality compliance means that pharmaceutical companies always adhere to all applicable regulatory requirements (cGMP, GLP etc.).
Q. What is Data Integrity?
Data integrity is a concept and process that ensures the accuracy, originality, completeness, consistency, and validity of data by following ALCOA and ALCOA+.
Q. What is ALCOA and ALCOA+?
ALCOA is a commonly used acronym for “attributable, legible, contemporaneous, original and. accurate”. And ALCOA+ added four extra criteria “complete, consistent, enduring and available”.
Q. What do You Mean by Cyber Security in Pharma?
Cybersecurity in pharmaceutical industry involves the protecting of electronic information and assets from unauthorized access, use and disclosure.
Related: Cybersecurity in Life Sciences and Medical Devices Industry
Q. What is Market Complaint?
Market complaint in pharmaceutical industry indicates the customer dissatisfaction regarding quality of product.
Q. What are the Common Data Integrity Issues in a Laboratory?
- Deletion/Overwrite of Data
- Back-door Manipulation
- Administrator Foul Play
- Manual reintegration etc.
Q. What are the Common Data Integrity Issues in a GMP Area?
- manipulated to generate desired results
- deleting or ignoring unfavourable data
- backdating or postdating
- repeated testing until meet the limit etc.
Q. What is a product recall?
A product recall is a way to remove or return a product from the market. This often occurs after the discovery of a safety issue or defect in the item that could harm the consumers.
Related: Drug Product Recall in Pharmaceutical Industry
Q. What are the major concern issues for material management in pharma industry?
- Training/qualification of personnel
- Identification of components, containers, and closures
- Inventory of components, containers, and closures
- Storage conditions
- Storage under quarantine until tested or examined and released
- Representative samples collected, tested, or examined using appropriatemeans
- At least one specific identity test conducted on each lot of each component
- Visual identification conducted on each lot of containers and closures
- Testing or validation of supplier’s test results for components, containers, and closures
- Rejection of components, containers, and closures not meeting acceptance requirements
- Full investigation of the establishment’s procedures for verification of the source of
components - Appropriate retesting/reexamination of components, containers, and closures
- First in—first out use of components, containers, and closures
- Quarantine of rejected materials
- Water and process gas supply, design, maintenance, validation, and operation
- Containers and closures are not additive, reactive, or absorptive to the drug product
- Control system for implementing changes in the materials handlingoperations
- Qualification/validation and security of computerized or automated processes
- Finished product distribution records by lot
- Documented investigation into unexpected discrepancies
- Risk management program for components: Documented when unacceptable levels of
hazardous impurities are identified by the establishment and updated as needed
throughout the product’s lifecycle
Q. What are the major concern issues for pharmaceutical manufacturing?
- Training/qualification of personnel
- Control system for implementing changes in processes
- Adequate procedure and practice for charge-in of components
- Identification of equipment with contents and, where appropriate, phase of manufacturing
or status - Validation and verification of cleaning/sterilization/depyrogenation of containers and
closures - Calculation and documentation of actual yields and percentage of theoretical yields
- Contemporaneous and complete batch production documentation
- Established time limits for completion of phases of production
- Implementation and documentation of in-process controls, tests, and examinations (e.g.,
pH, adequacy of mix, weight variation, clarity) - Justification and consistency of in-process specifications and drug product final
specifications - Prevention of objectionable microorganisms in non-sterile drug products
- Adherence to preprocessing procedures (e.g., set-up, line clearance)
- Equipment cleaning and use logs
- Master production and control records
- Batch production and control records
- Process validation, including validation and security of computerized or automated
processes - Ongoing statistical evaluations (e.g., batch control data, periodic capability analysis) to
identify processes that exhibit higher variability and trigger needed improvements - Change control; the need for revalidation evaluated
- Investigation into unexpected discrepancies
- Effective control strategy established for operations at risk of forming hazardous
impurities
Q. What are the major concern issues for pharmaceutical packaging?
- Training/qualification of personnel
- Acceptance operations for packaging and labeling materials
- Control system for implementing changes in packaging and labelingoperations
- Adequate storage for labels and labeling, both approved and returned afterissued
- Control of labels that are similar in size, shape, and color for different products
- Finished product cut labels for immediate containers that are similar in appearance
without some type of 100 percent electronic or visual verification system or the use of
dedicated lines - Gang printing of labels is not done, unless they are differentiated by size, shape, or color
- Control of filled unlabeled containers that are later labeled under multiple private labels
- Adequate packaging records that will include specimens of all labels used
- Control of issuance of labeling, examination of issued labels, and reconciliation of used
labels - Examination of the labeled finished product
- Adequate inspection (proofing) of incoming labeling
- Use of lot numbers, destruction of excess labeling bearing lot/control numbers
- Physical/spatial separation between different labeling and packaging lines
- Monitoring of printing devices associated with manufacturing lines
- Line clearance, inspection, and documentation
- Adequate expiration dates on the label
- Conformance to tamper-resistant packaging requirements (see 21 CFR 211.132 and CPG Sec. 450.500 Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products)
- Validation of packaging and labeling operations, including validation and security of
computerized processes - Documented investigation into unexpected discrepancies
Related: Inadequate Investigations: A Common Observation by the FDA
Q. What are the major concern issues for laboratory control system in pharma industry?
- Training/qualification of personnel
- Adequacy of staffing for laboratory operations
- Adequacy of equipment and facility for intended use
- Calibration and maintenance programs for analytical instruments and equipment
- Validation and security of computerized or automated processes
- Reference standards; source, purity, and assay and tests to establish equivalency to
current official reference standards as appropriate - System suitability checks on chromatographic systems (e.g., gas chromatography, highperformance liquid chromatography)
- Specifications, standards, and representative sampling plans
- Control strategy established for hazardous impurities if identified in components or the
finished product, or as a degradant, throughout the product’s lifecycle - Adherence to the written methods of analysis
- Validation/verification of analytical methods
- Control system for implementing changes in laboratory operations
- Required testing performed on the correct samples
- Documented investigation into unexpected discrepancies
- Complete analytical records from tests and summaries of results
- Quality and retention of raw data (e.g., chromatograms and spectra)
- Correlation of result summaries to raw data; presence of unused data
- Adherence to an adequate out-of-specification (OOS) procedure that includes timely
completion of the investigation - Adequate reserve samples; documentation of reserve sample examination
- Stability testing program, including demonstration of stability indicating capability of the
test methods
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