Plants process control, documentation

Adapting a commercial process to a controlled and well-documented pilot plant process... 

The level of control and validation documentation required (i.e., through increased testing and tighter specifications) increases as one moves closer, in a multistep, in-plant process, to the outcomes [i.e., final intermediate(s) and the API itself]. Naturally, when key and final intermediates are sourced from outside the company, they must enter with appropriate certificates of analysis (CofA), plus thorough inspections of off-site facilities by quality assurance personnel. 

During the OQ process, documented evidence is given that all parts of the plant and equipment work within their specifications and process parameters are within the acceptance criteria. Process controls that are part of the equipment (e.g., PLC [programmable logic controller]) will be qualified during the OQ process. Computerized process controls (i.e., for complex processes) should be qualified in the Computer Validation (CV) process. To ensure that the systems tested during OQ are doing what they are believed to do, a simulation of normal production conditions must be done. 

There are many examples of action to eliminate or reduce problems. As an example there is the Quality System Regulation (QSR). FDA requires details on how products such as medical devices are manufactured. The details of the process are documented so that once a product produced in USA is approved, following what was in the QSR preparation can only produce the product. No change can be made. The exact plastic composition has to be used, process control settings remain the same, etc. Literally if a waste paper basket had been identified and located in a specific location in the plant, you can not relocate, change its size, etc. It has been reported that to make a change could cost literally a million dollars. Result of the QSR regulation is too ensure the safety of a person when the medical device is used. 

Also the demand for in-process controls (IPCs) and documentation will be higher compared to non-GMP operations. The plant design needs to consider space for laboratories and offices. 

Method Transfer. Method transfer involves the implementation of a method developed at another laboratory. Typically the method is prepared in an analytical R D department and then transferred to quahty control at the plant. Method transfer demonstrates that the test method, as mn at the plant, provides results equivalent to that reported in R D. A vaUdated method containing documentation eases the transfer process by providing the recipient lab with detailed method instmctions, accuracy and precision, limits of detection, quantitation, and linearity. 

GPMP is concerned with the manufacture of medicines, and includes control of ingredients, plant construction, process validation, production, and cleaning (see also Chapter 22). QC is that part of GPMP dealing with specification, documentation and assessing conformance to specification. 

If the product is to be used for pharmaceuticals the GMP rules must be obeyed during plant operation. All chemicals to be tested in clinical studies with humans must be prepared according to GMP. This leads to very detailed documentation since if you haven t documented it, you haven t done it . All procedures for manufacturing and changes in procedures are subject to approval by quality control departments. This decreases the flexibility in process development. Products that are contaminated too much must be reprocessed according to the GMP guidelines. All equipment to be used in the pilot plant must be validated before use. 

Mainly comprised of plant protection products and biocidal products, pesticides are designed to influence fundamental processes in living organisms. They may have the potential to kill or control harmful organisms such as pests, but can also cause unwanted adverse effects on non-target organisms, human health and the environment (EC 2007). Both the hazards and benefits of pesticides are well documented in published literature and have been reviewed most recently by Cooper and Dobson (2007). 

Internal monitoring control and documentation of the decomposition respiratory digestion process by the plants... 

To maintain control of the computer system throughout its conception, implementation, and operational use in a GMP environment, it is required that the computer system application must be validated in a way that will establish auditable documented evidence that the computer system does what it is expected to do. As applicable, this needs to be carried out in conjunction with plant equipment to provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. The methodology to achieve this is based on a recognized life-cycle mode. 

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