SOPs , for

Provide an SOP for the determination of cadmium in lake sediments by atomic absorption spectrophotometry using a normal calibration curve. 

The plan should also address standard operating procedures (SOPs) for site operations to help minimize contact with hazardous materials. 

The contractor s SSAHP for Site C contained task- and operation-specific hazard analyses and safety and health procedures that covered general operations, but they were not specific enough for prescribing control methods and PPE for each job task. The plan identified some safety hazards for each operation but did not describe SOPs for protecting employees from these hazards. The SSAHP did, however, contain personnel and equipment decontamination procedures used at the site. 

Are employees aware of the existenee and loeation of SOPs for safely performing job tasks [OSHA Referenee. 120(d)(3)]... 

A site-speeifie safety and health plan that ineludes the employer s standard operating proeedures (SOPs) for safety and health [OSHA Referenee. 120(b)(l)(ii)(C), (F)]... 

What Is the Expected Output or Work Product. The specific form of the finished product will vaiy according to your company s practices and needs. However, it s reasonable to expect that the team s efforts will ultimately produce a set of documented Standard Operating Procedures (SOPs) for the management system, or their equivalent within your organization (see Section 6.3). Interim work products may include progress reports (see Chapter 8), documentation of discussions and analyses, flowcharts, or other materials. 

Dorgan, C. E., and Dorgan, C. B. (1999). Developing Standards of Performance (SOP) for lAQ in Building. In Proceedings oi the 8th International Conference on Indoor Air Quality and Climate. Edinburgh, Scotland. 

Several countries (Cyprus, Estonia, Venezuela and Zimbabwe) have adopted the WHO GMP guidelines (25) as their statutory GMP standards. Australia has its own GMP guidelines. Malaysia uses the GMP guidelines of the ASEAN (26). The Netherlands has adopted the European Union guidelines on GMP inspection (27). The majority of the countries have also developed SOPs for their inspectors, as indicated in Table 7.1. Australia, Cuba, Cyprus, Malaysia, Uganda and Venezuela have not developed guidelines for GDP. 

Please note the following Reference SOP for purging and sampling is WEI-8DD. Dedicated bladder pumps are used for purging and sampling. Sample IDs are listed on the Chain-of-Custody form. 

Another common problem is the failure to understand that, when using a merged system (some combination of paper and electronic records), both are the real SOPs, protocols, etc. As SOPs and protocols are transferred from paper to electronic media, frequently a signed, hard copy and an approved electronic version of the same document are maintained. Users of merged systems must remember that one must be able to demonstrate that the paper and electronic versions of an SOP, protocol, etc., are exactly the same. For example, if the SOP is signed on a certain date, the electronic version must also indicate that approval occurred on the same date. This means that a procedure (i.e., SOP) for ensuring document equivalency must be available and followed. 

An organized document filing system must be maintained. This could be a paper file, an electronic document file, or a mixture of both. The equipment inventory system contains key information on the components of each system, their performance criteria and maintenance and calibration status. All documents including installation and performance documentation, as with other documents necessary to demonstrate the quality of the data, include SOPs for the qualification procedures, calibration, maintenance, personnel training, etc. If the manufacturer s operating, service, or maintenance manuals are used or cited in the operating procedures, copies of these manuals should be maintained. To facilitate retrieval, documentation should be stored in a central location and be indexed for easy retrieval. 

Is there a SOP for archive requirements and retention policies (Is the archived material indexed, is there document control and is it secure )... 

The QA unit should have written procedures (SOPs) for the conduct of inspections and audits. These procedures should incorporate all considerations for the review of electronic data systems. The QA unit SOPs should address the role and responsibilities of the QA unit in software development, purchase, and validation activities, in-process audit procedures for data collected on line, procedures for on-line review of data (i.e., what will be verified and how much data will be reviewed), and the procedure for auditing reports using on-line data. 

In addition to observing the procedure being performed during the conduct of in-process inspections of chemistry analyses, the data collection practices and the data capture system should be inspected. The QA auditor should review the protocol and applicable SOPs for data collection practices and the procedure prior to conducting the in-process inspection. 

The facility inspection should include a review of the computer systems and software to ensure they have been validated. There may be differences between how network systems are validated in contrast to stand-alone systems. The records, procedures, and SOPs for the different systems should be reviewed as part of the facility inspection. If validation reports have not previously been reviewed by the QA unit, the facility inspection may provide an opportunity to review these reports and data. 

A physical component of IT life cycle management is storage media management. Tapes, disks, and other electronic media degrade over time. Optimally, they are refreshed every 10 years. Ideally, this is part of the SOPs for the data centers and archive facilities. 

Possible deviations from laboratory SOPs on data systems, lack of SOPs for the use and generation of electronic data capture... 

USDA Microbiological Data Program, SOPs for laboratory activities, 2005. http //www.ams.usda.gov/science/MPO/SOPs.htm... 

Consider the VMP as the corporate doctrine of a corporation s general validation, testing, recording and archival practices. Typically, the SOPs within the VPM are too general and, therefore, it is advised that one create specific SOPs for a particular system to be validated. These would be part of an HPLC system s validation plan. Note that the VMP should be thought out and drafted well in advance of developing a specific system Validation Plan. 

As an example, consider an incident where an employee is exposed while sampling chlorine. One of the root causes is determined to be an inadequate standard operating procedure (SOP) for sampling. A management of change system can provide a mechanism to identify things that... 

The next two slides describe the typical content of a SOP for a test method a general description to give an overview... 

The extent of a SOP depends also on the qnalffieation of the staff. If this is high, the SOP eanbe mneh shorter eompared to an SOP for low qualified staff. 

Promotional activity and the dissemination of information are so closely linked that it is hard to see where one ends and the other begins. In the modern era, where many pairs of eyes are on the industry s activities, eager to criticise and to control, the only real option for companies is to conform to the rules and to play fair. I would suggest that since companies act by SOPs for their conduct of clinical trials, so it makes sense to have an SOP for the preparation and approval of ethical promotional material. If one does not create written procedures to cover the multiple steps in the preparation and approval of promotional copy, mistakes can be made and complaints may follow. 

The new GCP requires clinical study sites to have enough facilities to conduct clinical trials and be able to cope in the case of emergency. Adequately trained staff should be available. The sites must prepare SOPs for accepting, reviewing and operating clinical trial. Additional SOPs are required for the operation of the Institutional Review Board (IRB). A clinical trial office and an office for IRB operation must be established in the study site. These requirements have been defined as the minimum requirements for any clinical trial to be conducted in hospitals equipped with ample resources, to manage many SOPs, and office staff for clinical trial and IRB. 

In addition to IRB members, the head of the institute must appoint a study drug manager, a document archiving manager and administration staff for both clinical trials and the IRB. In order to handle clinical trials in such a complex structure, SOPs for conducting clinical trials must be prepared at the hospital. 

SOPs can be both general and specific. Examples of general laboratory operations include how to characterize an analytical standard, how to record observations and data, and how to label reagents and solutions. Most laboratory operations even have an SOP for writing and updating SOPs. Examples of specific laboratory operations include the preparation and analysis of a specific company s product or raw material, the operation and calibration of specific instruments, and the preparation of specific samples for analysis. Often, SOPs are based on published methods, such as those found in scientific journals, in application notes, and procedures published by instrument manufacturers, or in books of standard methods, such as those published by the American Society for Testing and Materials (ASTM) and the Association of Official Analytical Chemists (AOAC). The published... 

All current SOPs should be available in the work area in which they are used. Each person who may need specific SOPs for his/her work should also have them, perhaps in a file near his/her desk. In addition, there should be a location in which master SOPs for all activities are filed and all SOPs should also be archived so that past revisions are accessible. All obsolete SOPs, however, should be removed and filed away from the work area and clearly identified as obsolete. The decision to revise an SOP must be based on sound observations and protocols that point to improved data accuracy and integrity. Such decisions can be based on a new procedure, a new piece of equipment, etc. SOPs are dynamic documents and should be considered for revision on a regular basis with input from the technicians and scientists doing the work. 

Write an SOP for the calibration of an analytical balance. Include a revision number, an indication of what SOP it replaces, the effective date, the purpose, the scope, the outline of the procedure, and references. Also include your name under "prepared by" and another name for "approved by."... 

Standard operating procedure (SOP) for the assay of paracetamol tablets... 

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