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Certified Pharmaceutical Good Manufacturing …

Certified Pharmaceutical good Manufacturing Practices Professional Quality excellence to enhance your career and boost your organization's bottom line Certification from ASQ. is considered a mark of quality excellence in many industries. It helps you advance your career, and boosts your organization's bottom line through your mastery of quality skills. Becoming Certified as a Pharmaceutical GMP Professional confirms your commitment to quality and the positive impact it will have on your organization. 2 Certified Pharmaceutical GMP Professional Information Certified Pharmaceutical good Manufacturing Practices Professional The Certified Pharmaceutical good Manufacturing Practices Professional understands the GMP principles as regulated and guided by national and international agencies f

2.Audit follow-up Use various methods to evaluate and verify the adequacy of corrective actions taken. (Evaluate) 3.Ineffective corrective actions

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Transcription of Certified Pharmaceutical Good Manufacturing …

1 Certified Pharmaceutical good Manufacturing Practices Professional Quality excellence to enhance your career and boost your organization's bottom line Certification from ASQ. is considered a mark of quality excellence in many industries. It helps you advance your career, and boosts your organization's bottom line through your mastery of quality skills. Becoming Certified as a Pharmaceutical GMP Professional confirms your commitment to quality and the positive impact it will have on your organization. 2 Certified Pharmaceutical GMP Professional Information Certified Pharmaceutical good Manufacturing Practices Professional The Certified Pharmaceutical good Manufacturing Practices Professional understands the GMP principles as regulated and guided by national and international agencies for the Pharmaceutical industry.

2 This covers finished human and veterinary drugs and biologics, ectoparasitacides, and dietary supplements (alternatively called nutraceuticals where regulated as drug products), as well as their component raw materials (includes active Pharmaceutical ingredients (APIs) and excipients) and packaging and labeling operations. Examination quality system, evaluate various Each certification candidate is required types of audits and self-inspections, to pass a written examination that and analyze documents and record consists of multiple choice questions that management systems.

3 Measure comprehension of the Body of Will be able to distinguish between Knowledge. The Pharmaceutical GMP and verify suitability of factors Professional examination is a one-part, relating to laboratory systems, 150 question, four-hour exam and is including relevant compendia for the offered in English. United States, Europe, and Japan, investigations of aberrant laboratory Education and/or Experience results, and instrument control and You must have five years of on-the-job record-keeping. experience in one or more of the areas of the Certified Pharmaceutical GMP Will be able to determine Professional Body of Knowledge.

4 A requirements and specifications for minimum of three years of this experience construction of facilities, utilities and must be in a decision-making position. equipment, evaluate automated or Decision-making is defined as the computerized systems, and apply authority to define, execute, or control business continuity plans and disaster projects/ processes and to be responsible recovery techniques. for the outcome. This may or may not Will be able to use sampling plans and include management or supervisory apply procedures for shipping and positions.

5 There are no education waivers receiving materials, analyze in-house for this exam. storage, identification, and rotation of For comprehensive exam information materials, and meet requirements for on the Pharmaceutical GMP Professional materials traceability and sourcing, certification, visit including returned goods. Will have a thorough understanding of Minimum Expectations for a sterile and nonsterile Manufacturing Certified Pharmaceutical GMP systems and be able to analyze master Professional and completed batch records, material control procedures, and contamination Will have a fundamental controls.

6 Understanding of regulatory agency governance, including global Will have a thorough understanding regulatory framework, relevant of product design factors and phase- regulations and guidelines, and appropriate GMP requirements. Will mutual recognition agreements. be able to develop and evaluate filling and packaging operations and Will be able to develop and apply controls, and analyze technology elements and requirements of a transfer activities. Certified Pharmaceutical GMP Professional 3. Body of Knowledge Certified Pharmaceutical GMP.

7 Professional (CPGP). Topics in this body of knowledge (BOK) cover compliance with good Manufacturing practices (GMPs), as regulated and guided by national and international agencies for the Pharmaceutical industry. It covers finished human and veterinary drugs and biologics, ectoparasitacides, and dietary supplements (alternatively called nutraceuticals where regulated as drug products), as well as their component raw materials (including active Pharmaceutical ingredients (APIs) and excipients) and packaging and labeling operations.

8 This BOK includes subtext explanations and corresponding cognitive levels for each topic or subtopic. These details will be used by the Examination Development Committee as guidelines for writing test questions and are designed to help candidates prepare for the exam by identifying specific content that can be tested. The subtext is not intended to limit the subject matter or be all-inclusive of what might be covered in an exam, but is intended to clarify how topics relate to the role of the Certified Pharmaceutical GMP Professional (CPGP).

9 The descriptor in parentheses at the end of each subtext entry refers to the highest cognitive level at which the topic will be tested. A more comprehensive description of cognitive levels is provided at the end of this document. Therapeutic Goods Administration I Regulatory Agency (TGA), USDA 9 CFR, USDA Veterinary Governance (15 Questions) Service Memoranda, and the A. Global regulatory framework International Pharmaceutical Identify the acts, statutes, directives, Excipients Council (IPEC). etc., that apply to pharmaceuticals.

10 (Understand). (Understand) C. Mutual recognition agreements B. Regulations and guidances Interpret requirements that govern Interpret frequently used regulations product registration, import or export and guidelines/guidances, including of raw material or finished product, those published or administered the sharing of inspection findings, etc. by the Pharmaceutical Inspection (Understand). Convention and Pharmaceutical D. Regulatory inspections Inspection Cooperation Scheme Define and describe various types (PIC/S), Health Canada, the World of inspections (pre-approval (PAI), Health Organization (WHO), the system-based, for-cause, license International Conference on renewal, etc.)


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