Facilities change control

The special process feature for case 3 is a relatively high reaction enthalpy in combination with a low maximum permissible temperature Texo- An alternative safety solution would be to control both these two parameters. For example by adding a pump to the reactor and with solvent makeup the process can be made continuous (CSTR). This allows the adoption of a higher maximum permissible temperature Texo, because of the short residence time and the dilution effect, and a reduction of the adiabatic temperature increase ATadiab because of the dilution effect. Such a (drastic) process and facility change will always require an iterative safety-technical reaction PHA furthermore additional may become necessary. 

Quality System This consists of procedures and specifications to assure the overall compliance for the facility. Quality control, change control, batch release, internal audits, and quality records are part of the quality system. 

To make any changes in existing equipment configuration, parts, or software or in utilities (HVAC), facility systems, etc., the engineering change control form will be raised. 

Sound development package in place Ranging studies completed and documented Facility qualification completed and documented Equipment qualification completed and accepted Appropriate analytical methodology implemented and validated Personnel training completed and documented Process trials and demonstrations executed and documented Change control in place and effective... 

Change control Complaints and recalls Contract manufacturers and laboratories Agents, distributors, repackers, and relabelers Specific guidance for API manufacture by cell culture or fermentation APIs for use in clinical trials (quality, equipment, facilities, control of raw materials, production, validation, change control, laboratory controls, and documentation)... 

Process validation of an API should include an SOP to reassess a process whenever there are significant changes in the process, equipment, facilities, reactants, process materials, systems, and so on that may affect the critical quality attributes and specifications of the API. Such changes should be documented and approved in accordance with the scope of the change control SOP. The change control SOP should consist of the following elements ... 

The implementation of a change control system is an important and necessary step in the validation approach for equipment and facilities. Vital to any change control system is its efficiency in that it does not require too much time and effort to handle changes. In order to design an efficient change control system, the following aspects need to be taken into consideration ... 

All validation activities should be planned. The key elements of a validation program should be clearly defined and documented in a validation master plan (VMP). The VMP should be a summary document which is brief, concise and clear. The plan should contain at least the following validation policy, organizational structure of validation activities, summary of facility systems, equipment and processes to be validated, documentation format, planning and scheduling, change control and reference to existing documents. 

In practice, the sheer nature of the dynamic validation process results in a substantiation of the original validation throughout the useful life of the method. As previously mentioned, a well-developed and-written method includes system suitability that must be met each time the method is performed. Additionally, the pharmaceutical industry has standardized on the need of formal method transfer exercises whenever an analytical method is to be performed by a different laboratory or in another facility. Also, change control procedures may require the revalidation of part or all of the method in the event of changes to the method, the process, or the formula of a drug product. The QAU should therefore have a system to formally monitor the... 

Facilities and Equipment Systems (including equipment IQ/OQ, computer qualihca-tion/validation, security, calibration and maintenance, and change control)... 

Sensitive balance with the saipple pan inside a furnace whose temperature can be accurately controlled and programmed for change. Facilities for controlling the atmosphere of the sample. Electronic integration and derivative curve presentation. 

To provide mechanisms for ongoing process optimization and ensure a continuing state of process control, a formal change control system should be established to evaluate and approve proposed changes to specifications, test procedures, raw materials, facilities, support systems, equipment (including computer hardware), processing steps, packaging materials, and computer software. 

The role of QA must be properly defined and implemented QA should at least be involved in vendor reviews and/or audits and the change control process and perform system-specific audits and audits of the central computer services facilities. 

A method to evaluate, authorize, implement, communicate, and document changes to process technology, chemicals, equipment, procedures, facilities, buildings, or organizations as to their potential for hazards, potential consequential loss, the magnitude of the potential risk, and the impact on facility operation. Control by means of elimination or mitigation of the hazards and/or the consequences should then be implemented to minimize potential risk. See Figure M.l for a flowchart of a typical MOC procedure. 

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