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ASQ CPGP Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Facilities and Equipment Systems18%-22%- Equipment
  • 1. Calibration and maintenance
  • 2. Equipment cleaning
  • 3. Qualification and validation
- Facilities
  • 1. Utilities and environmental controls
  • 2. Cleaning and sanitation
  • 3. Facility design and maintenance
Topic 2: Packaging and Labeling Systems5%-9%- Packaging controls
  • 1. Packaging inspections
  • 2. Label issuance and reconciliation
  • 3. Tamper evidence
Topic 3: Laboratory Systems10%-14%- Laboratory operations
  • 1. Microbiology controls
  • 2. Stability programs
  • 3. Analytical testing
  • 4. Data integrity
Topic 4: Production Systems23%-27%- Manufacturing operations
  • 1. Packaging and labeling
  • 2. Contamination control
  • 3. Process validation
  • 4. Batch processing
Topic 5: Materials Systems13%-17%- Material controls
  • 1. Inventory control
  • 2. Incoming material inspection
  • 3. Supplier qualification
  • 4. Storage and distribution
Topic 6: Quality Management Systems22%-26%- Quality systems
  • 1. Documentation systems
  • 2. GMP regulations and guidance
  • 3. Quality culture
  • 4. Training systems

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q193-Q198):

NEW QUESTION # 193
Contamination controls in filling operations are designed to prevent:
(Select two)
Response:

Answer: B,D


NEW QUESTION # 194
The re-evaluation and revalidation of unit processes should be based on:
Response:

Answer: C


NEW QUESTION # 195
The EMA is a key regulatory body in the pharmaceutical industry. Which region does it serve?
Response:

Answer: D


NEW QUESTION # 196
Critical Process Parameters (CPPs) are defined as:
Response:

Answer: A


NEW QUESTION # 197
The main reason for ensuring equipment failure detection is to:
Response:

Answer: C


NEW QUESTION # 198
......

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