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Index
»
MANUFACTURING LAB
»
Chapter 2
»
Section 1
level: Section 1
Questions and Answers List
Organization, Qualification and Responsibilities
level questions: Section 1
Question
Answer
There shall be an adequate number of personnel at all levels having knowledge, skills and capabilities relevant to their assigned functions, in good mental and physical health to be able to execute their duties.
Section 1
The organizational structure of the company shall be such that the production and the quality assurance are headed by different __, neither of whom shall be responsible to the other. Each shall be given full authority and facilities necessary to execute his/her duties effectively. Neither shall have any interests outside the manufacturer’s organization that prevent or restrict their dedication to the assigned responsibilities or which may be considered to entail a conflict of interest.
managers
The __ shall be a PRC registered qualified pharmacist or any other related profession. He/she shall be adequately trained and shall posses good practical experience in the field of pharmaceutical manufacture and managerial skill, which enable him/her to perform his/her function effectively. The __ shall have full authority and responsibility to manage production of drug products.
production manager
The __ shall have full authority and responsibility in all quality control processes such as establishment, verification and implementation of all quality control procedures. He/she shall have the sole authority to approve starting materials, intermediates, bulk and finished products that meet the specification or to reject those which do not conform to the relevant specification or which are not manufactured in accordance with the approved procedures. The __ shall clearly define the field of work and the method of delegating responsibilities in his/her absence.
quality assurance manager
The __ shall be a PRC registered qualified pharmacist or any other related profession. He/she shall have adequate training and practical experience that will enable him/her to perform his/her function effectively.
quality control manager
The __ shall have personal and professional responsibility for ensuring that various checks and tests have been carried out. The details of this work may be delegated to an appropriately trained and experienced staff who would endorse their work. Finally, the __ has to be satisfied directly by the proper operation of quality systems that include appropriate approvals, audits, self-inspections and spot checks that the production and testing have complied with relevant requirements.
quality assurance manager
are jointly responsible to establish for the quality, strength, purity and efficacy of the finished products.
1 production manager and the 2 quality assurance manager
To support and assist the key personnel, an adequate number of qualified personnel should be available in the __ Each personnel shall be adequately trained with their respective assignment.
production and quality assurance.
The duties and responsibilities of all employees shall be clearly defined, well understood and shall be within his/her capacity to perform to ensure quality products. True or False
TRUE
