Document control process

It is extremely important for GLP compliance that all records related to the nonclinical laboratory study are in a document control process. As mentioned previously, this is a challenging hurdle for most laboratories and one that often is the crux of... 

In the nonclinical laboratory, it is primarily the role of the study director and the QAU to set up these document control processes and monitor the documents and records produced throughout the study to make sure GLP regulations are being followed. 

These elements of ISQ/TS 16949 are linked together as shown in Figure 2.1. In the figure, document control and management are functions common to other elements of the business, and the education and training process is shown separately as it operates in both the implementation and the design phase. 

The standard also requires documents such as FMEA, control plans, etc. to be marked with the customer s specific symbols to indicate those process steps that affect special characteristics. As the characteristics in question will be specified within documents, the required symbols should be applied where the characteristic is mentioned rather than on the face of the document. For drawings, the symbol should be applied close to the appropriate dimension or item. Alternatively, where a document specifies processes that affect a special characteristic, the appropriate symbol should be denoted against the particular stage in the process that affects that characteristic. The symbols therefore need to be applied during document preparation and not to copies of the document. The instructions to apply these symbols should be included within the procedures that govern the preparation of the documents concerned. 

The principal elements of document control are illustrated in Figure 5.5. This process provides for bringing existing documents under control, for controlling the preparation of new documents and for changing approved and issued documents. Each process could represent a procedure or a form. The processes may differ depending on the type of documents and organizations involved in its preparation, approval, publication, and use. One procedure may cater for all the processes but you may need several. 

Processes in this context means those series of related activities that turn inputs into outputs of added value. They include design, procurement, manufacture, packing, delivery, installation, maintenance, operations, disposal as well as the processes which serve these primary processes such as calibration, training, inspection, test, document control, etc. 

Process validation is intended to show and document that the process described, when operating within the designated parameters, will produce product of the appropriate quality and demonstrate that the manufacturing process is under full control. Process validation should extend from laboratory-scale and preformulation studies (say to of production scale) to formulation to pilot-scale manufacture (say production scale) to full industrial-scale manufacture, with a clear, logical, and continuous path between these stages. The magnitude of scale-up at each stage should not normally exceed a factor of 10. 

As has already been mentioned in Chapter 2, ISO 9001, Management Systems - Requirements , is increasingly being adopted by laboratories to cover the aspects of their business that are not laboratory based. This is because this Standard is more about controlling the process and service enhancement rather than technical issues. It requires continuous improvement, demonstrating that quality is not a static process. The requirements for such matters as documentation, document control, purchasing and management responsibilities are much the... 

The records include the construction organization s documentation of the testing and quality control processes (see para. IP-10.13 and Chapter GR-6). 

Procedural controls, process controls, 98-99 Process controls, 96-100 active controls, 98 inherently safer approach, 97 mitigation techniques, 99 passive controls, 97-98 procedural controls, 98-99 safe operating limits, 99-100 Process definition, documentation, 102-104 Process design, documentation, 105 Process hazard analysis (PHA) risk assessment, 92-93 screening methods, 63 Process risk management decisions, documentation, 105-106... 

The mission of process chemistry in the pharmaceutical industry is to provide documented, controlled synthetic processes for the manufacture of the supplies to support the development programs and future commercial requirements of the API. The science and technology associated in accomplishing this mission provides a... 

Documentation will typically comprise validation life-cycle documents and procedures, SOPs, training records, quality records and procedures, process and engineering data, drawings, manuals, and spares list(s), and includes copies of the software. These originate from both the pharmaceutical manufacturer and the supplier. The documents must be verified as approved and on file under a document control system. The documentation must be located or stored in a controlled environment. 

Performance qualification is documented verification that the computerized operation (comprising the controlled process and the computer system) consistently performs as intended in the URS throughout all anticipated operating ranges. 

Equipment calibration. This quality function for production consists of a viable calibration program for equipment that provides in-process test data or a measurable indication of the controlled process used. This activity is needed so that the manufacturing unit will know whether the equipment is operating consistendy during the time period covered by the calibration activity. This effort is also a continuing commitment of production to maintain its equipment as it was documented to perform during its installation qualification (IQ) and operational qualification (OQ) activities. 

Use of clear, precise operating instructions, including the documentation of process performance and verification. A company s system includes the issuance of a master production and control record and the batch production and control record (for each batch). These records document the fact that the company continues to manufacture each batch of product with the validated process of record. 

Qualification is the process of demonstrating whether a computer system and its associated controlled process/operation, procedural controls, and documentation are capable of fulfilling the specified requirements. Sidebar 10-11 depicts the context of the qualification activities and the computer systems validation process. The physical components of the systems are reviewed and its specific elements, subunits, and parameters are documented. A qualification also serves to verify and document the acceptability of the design, implementation, integration, and installation of the computer system components. The execution of the qualification is the mechanism by which documented evidence is created that verifies that the computer system performs according to its predetermined specification. 

Qualification practices apply to all components of a computer system and its associated controlled process/operation, procedural controls, and documentation. Any of these components can be purchased or developed by the company or by a computer technology supplier/contract developer. 

The following practices are applicable to the integrated computer system (which include the controlled process, operating procedures, and supporting documentation) that performs regulated operations ... 

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