Standard operating procedures preparation

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

In the author s experience, field residue trials can be conducted in Latin America under complete compliance with all ERA guidelines and recommendations. More time does need to be spent in planning and preparation to ensure that the personnel involved in the testing have been trained in GLP and that this training, as well as the compliance of equipment, storage and archival sites, standard operating procedures (SOPs), and quality assurance (QA) audits, are properly documented. 

All six samples at both sites were prepared the same way. Five separate aliquots from each sample were separately sampled and prepared for testing. Each aliquot was then measured three times. Conditions and standard operating procedures for METHODS A and B were carefully specified for both Labs 1 and 2. 

The methods to be used and a copy of Standard Operating Procedures (SOPs) where accredited, including any sampling and sample preparation protocols, to be supplied to the customer. 

Results Standard operating procedures (SOPs) have been prepared for each method developed. 

Traditionally, the education that chemists and chemistry laboratory technicians receive in colleges and universities does not prepare them adequately for some important aspects of the real world of work in their chosen field. Today s industrial laboratory analyst is deeply involved with such job issues as quality control, quality assurance, ISO 9000, standard operating procedures, calibration, standard reference materials, statistical control, control charts, proficiency testing, validation, system suitability, chain of custody, good laboratory practices, protocol, and audits. Yet, most of these terms are foreign to the college graduate and the new employee. 

The laboratory quality control program has several components documentation of standard operating procedures for all analytical methods, periodic determination of method detection levels for the analytes, preparation of standard calibration curves and daily check of calibration standards, analysis of reagent blank, instrument performance check, determination of precision and accuracy of analysis, and preparation of control charts. Determination of precision and accuracy of analysis and method detection limits are described under separate subheadings in the following sections. The other components of the quality control plan are briefly discussed below. 

The preparation of the samples for analysis and the analyses itself will be performed by the IT using its own equipment approved for this purpose. Sample preparation and analysis is conducted in accordance with OPCW standard operating procedures (SOP) and work instructions (WI) applying OPCW QA/QC criteria. 

Standard Operating Procedure (SOP) SOP-LAB-EQP-005, Bruker EM640S Portable GC/MS with AMDIS Data Analysis Software (Blinded Mode) for Qualitative Analyses of Liquid Samples Prepared by On-site Methods, Version 3, The Technical Secretariat of the Organization for the Prohibition of Chemical Weapons, The Hague, 1999. 

The OPCW has created the following quality system documents to control the proficiency testing. The documents are Standard Operating Procedure for the Organization of OPCW Proficiency Tests (QDOC/LAB/SOP/PT1), Work Instruction for the Preparation of Test Samples for OPCW Proficiency Tests (QDOC/LAB/WI/PT2), and Work Instruction for the Evaluation of the Results of OPCW Proficiency Tests (QDOC/LAB/WI/PT3). 

Standard Operating Procedures (SOPs) are prerequisite for any process involving the preparation of an Active Pharmaceutical Ingredient (API) and effectively provide an instruction of what to do. With reference to preparative HPLC there will be an SOP for each step and this may stretch back as far as an SOP to describe the format and units used in writing an SOP. 

Within the entire workflow described above the standardization of sample preparation [implementation of standard operating procedures (SOPs)], analyzing procedures and data handling will assure the comparability of results within the network as well as with results outside the consortium. Thus, the standardization is essential for efficient networking. 

Batch documentation is an important factor. Preparation of master batch records in accordance with plant standard operating procedures (SOPs) should be followed by an approval of the document by the sponsoring division, usually the formulator or process development staff of the R D unit. On completion of a batch, review of the batch records by the quality assurance group ensures compliance to GMP and that all necessary deviations from and modifications to the manufacturing records are properly explained and documented. 

Britain breaks down the preparation of a standard operating procedure into six stages ... 

Write user in- Prepare standard operating procedure... 

PMS managers shall prepare standard operating procedures for PMS in order to collect information on drug use, assess this information and take appropriate measures, undertake surveys and special surveys when necessary, perform post-marketing clinical trials, conduct selfinspections, train and educate PMS personnel,... 

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