Responsibilities and Procedures

The employer is responsible for developing and implementing written operating procedures that provide dear instructions for safely conducting activities involved in each covered process consistent with the process safety information by addressing requirements, responsibilities, and procedures for ... 

Responsibility and procedure for notification of Adverse Drug Reactions (ADRs) or other unexpected or unusual occurrences in compliance with the legislation needs to be described. 

U.S. Food and Drug Administration, Team Biologies, Standard Operating Procedures Core Team Responsibilities and Procedures, n.d. 

Violations of 21 CFR 122d (failure to create adequate, written responsibilities and procedures for the quality control unit or failure to follow them), occurring in 42% of the 483 s... 

Maintain QA procedural controls for responsibilities and procedures, and make them... 

MaPPs are approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities. MaPPs define external activities as well. All MaPPs are available for the public to review to acquire a better understanding of office policies, definitions, staff responsibilities, and procedures. 

Also known as Disaster Recovery procedures. These detail responsibilities and procedures in the event of major system maloperation/failure, e.g., database corruption, and need to be periodically reviewed/rehearsed and proven effective. 

Quality Plan GAMP Forum (1996) A plan created by the supplier to define actions, deliverables, responsibilities, and procedures to satisfy the customer s quality and validation requirements. 

In addition, per U.S. GLPs, the responsibilities and procedures of the QAU, all records it maintains, and the method of indexing such records must be in writing and continually maintained. Required records include internal audit (inspection) dates, the studies inspected, the phase of each study inspected, and the name of the... 

A Reference Standards Control and Use Standard Operating Procedure (SOP) would typically include assigned responsibilities and procedures to ensure that ... 

Responsibility and procedures for recall of drug products should be established.by the manufacturer to facilitate the recall of a batch from any link of the distribution chain when this becomes necessary. 

The responsibilities and procedures applicable to the quality control unit should be in writing and followed. 

When a system is more complex and there are more potential sources of dynamic variations, a more complicated control is required. Particularly in automatic systems where human operators are replaced by machines and computers, a thorough design of control responsibilities and procedures is necessary. Control activities include automatic control of individual machines, material handling, equipment, manufacturing processes, and production systems, as well as control of operations, inventory, quality, labor performance, and cost. Careful design of correct and adequate controls that continually identify and trace variations and disturbances, evaluate alternative responses, and result in timely and appropriate actions is therefore vital to the successful operation of a system. 

A description of the company environmental management structure including staff, relationships, responsibilities and procedures of implementation of policies and goals in the organisation should be provided. This should include information on the environmental management system in place, programmes of improvement of environmental performance. Examples of reports providing this are National Westminster Bank Pic 1994, Daimler Benz 1995, Pharmacia 1994, and Baxter 1994. 

Fire Precautions drills, maintenance of exit routes, regular maintenance. Hazards risk assessments/responsibilities and procedures (see Chapter 3 for further details). 

The concept of a quality management system is familiar. Such a system (for example, ISO 9000) defines the roles, responsibilities and procedures necessary for achieving quality in meeting an organisation s objectives. 

Lithium thermal batteries designed for use in U.S. Navy systems are subject to safety tests per Navy technical manual S9310-AQ-SAF, Battery, Navy Lithium Safety Program Responsibilities and Procedures. These tests are designed to assure that the battery design is safe not only in proper storage and use, but also when subjected to inadvertent misuse and conditions caused by accidents, such as backcharging, short circuits, and fires. 

Occupational noise and ventilation are occupational environmental problems that have to be dealt with. Chapter 11 gives guidance about responsibilities and procedures to deal with these problems. 

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