Documentation specifications

Are there documented specifications for all incoming raw materials used m products ... 

If the control valve size is critical to the overpressure protection of the downstream equipment, and must not be increased, then this is clearly noted in all relevant documentation (specification sheets, flow diagram, operating manual, etc.,) and a warning notice plate is welded to the valve body. In such cases, an actual check of the valve installed or purchased should be made during the startup review. 

Included in this element are requirements for purchasing documents (specifications, drawings, and purchase orders), selection of suppliers, inspection and control of received material and record-keeping. For ESH/PSM, this element would focus on those aspects of the procurement process which support purchasing according to regulatory requirements, safety standards, risk management controls, etc. 

In analytical chemistry, we do not have a standard mole. Therefore, solutions made up to a well-defined concentration using very pure chemicals are used as a basis from which we can compare other solutions or an instrument scale. This process is calibration . For some analyses, the chemical used may be a Certified Reference Material which has a well documented specification, e.g. in terms of the concentration of a particular species and the uncertainty of the specified value. However, it is not sufficient just to calibrate the apparatus/equipment used, it is important that the complete method of analysis is validated from extraction of the analyte from the sample to the final measurement. 

Tests or verification documents—specifications of correct behavior, concrete initialization and test data, expected results, and actual results. 

Module 1 Administrative information and prescribing information. This contains documents specific to each region including (e.g. application forms or the proposed label for use in the region) the content and format of this module will be specified by the relevant regulatory authorities. 

Documents specific to each region (e.g. appUcation forms, prescribing information)... 

Verify and document specifications on purchase order against actual delivery. 

I believe that by following the broadly based example of these SOPs, new as well as experienced companies can benefit by enhancing their existing documentation to meet FDA and other regulatory requirements. Currently, no GMP document specifically describes the format of these validation SOPs. 

The contract describes the conditions of handling the customer-supplied product (or by other documented specification). 

The products received from the customers are verified, stored, and maintained to prevent deterioration or loss. The conditions of handling and use of customer-supplied product are spelled out in the contract or by other documented specifications. Any customer-supplied product that becomes nonconforming is segregated from the production stream, recorded, and reported to the customer. 

The documents shall be verified, approved, and filed essential documents are the protocol, records for operation, in-process control parameters, change control document, specification test as quality control, and final report. 

In this definition, the key words are documentation, specific process, product specifications, and quality. This automatically means that validation will play a vital role in guaranteeing the safety, identity, quality, and stability of all pharmaceutical, biological, and medical device products. We will now present an outline of the most important requirements for ensuring that packaging line equipment complies with the guidelines of the authorities. 

Inspection A manual testing technique in which program documents [specifications (requirements, design), source code or user s manuals] are examined in a very formal and disciplined manner to discover any errors, violations of standards or other... 

Nearly every application has a required FDA transmittal form. Transmittal forms are primarily screening tools and are used to identify the information required and also provide administrative information for the application. Electronically generated forms may be used, provided the FDA approves the form prior to its initial use. A copy of FDA s approval letter should accompany the form the first time it is submitted. In some instances in which there are no transmittal forms, specific cover sheets or checklists are recommended. These are found within the guidance documents specific to the application type. 

Germany does not have an official chemicals policy, nor is a chemicals policy available from any of the Ministries. The only publicly available document specifically relating to national chemicals policy is a report on the Precautionary Risk Assessment and Risk Management of Chemicals produced by the Federal Environment Agency (UBA). The UBA report does not appear to receive strong support from the ministries as it fails to appear on the Ministry for the Environment s website, although an interviewee stated that the UBA has to receive permission prior to any official publication. It is not unusual for the Ministry for Environment and the UBA to form separate environmental policy [370]. Neither is it uncommon for the UBA staff to publicly criticise the concepts put forward by the ministry [370]. 

Only provide documentation specifically requested. Provide copies of requested documents as per company SOP in a timely manner. Lengthy lag times in responding will make the inspector suspicious that there is a problem. Some questions are appropriate to answer quickly such as SOPs some require slower response such as technical detail. Inspections of computer systems are predicated on the assumption that pharmaceutical and healthcare companies have effective record retention and retrieval systems. Significant problems may arise during inspections where these systems are inefficient or ineffective. ... 

Once the responses to the challenges are known, the nature of the areas of noncompliance (if any) as well as the remedial action plans should be documented in a summary and conclusions document specific to the given platform/network/architecture. 

Validation of instrument hardware includes testing according to documented specifications. If HPLC instruments consist of several modules, individual modules (modular validation), as well as the entire system (holistic validation), should be validated. However, the latter is preferred, as individual module tests should be performed as part of the diagnosis if the system fails. 

AMS standards and for all Military and Federal standardization documents (specifications, standards, handbooks) and DOD Adopted industry standards when known. 

Instrument vendors use the term qualification for installation and both verification and qualification for testing the equipment hardware and software for documented specifications prior to operation. For software development typically the term validation is used, although the term verification would be more appropriate. 

The pharmacist uses the medical record as one means to communicate with other health care professionals and to document specific pharmacotherapeutic recommendations. 

Several studies have concluded that market orientation is important for the successful outcome of innovation and this has also been documented specifically for the food industry (Kristensen et ah, 1998). Market... 

---