Premises inspections

To make regulatory control effective, the regulatory agency must have the right to enter premises for inspection and testing, to require the owner to monitor and report noncompUance, and, where necessary, to do the testing. 

Laboratories wishing to claim GLP compliance are nonually registered with Competent Authorities who issue statements of compliance following successful periodic inspections of the premises to monitor compliance with the relevant legislation. In the UK compliance with the Good Laboratory Practice Regulations 1999 is audited by the Medicines Control Agency. 

Quality control is also the term used as the name of a department. In most cases Quality Control Departments perform inspection and test activities and the name derives from the authority that such departments have been given. They sort good products from bad products and authorize the release of the good products. It is also common to find that Quality Control Departments perform supplier control activities, which are called Supplier Quality Assurance or Vendor Control. In this respect they are authorized to release products from suppliers into the organization either from the supplier s premises or on receipt in the organization. 

The quality of the product can be verified by you witnessing the final acceptance tests and inspections on the subcontractor s premises. (If you don t possess the necessary equipment or skill to carry out product verification, this method is an economic compromise and should yield as much confidence in the product as the previous methods. You do, however, need to recognize that your presence on the subcontractor s premises may affect the results. They may omit tests which are problematical or your presence may cause them to be particularly diligent, a stance which may not be maintained when you are not present.)... 

It is important that you inform the subcontractor through the contract of how the product or service will be accepted. Will it be as a result of receipt inspection at the specified destination or as a result of acceptance tests witnessed on site by your authorized representative These details need to be specified at the tendering stage so that the subcontractor can make provision in the quotation to support any of your activities on site. If you have invoked ISO 9001 in the subcontract, you are protected by clause 4.6.4.2. If you have not, you need to specify a similar provision in your subcontract, otherwise you may lose the right to reject the product later. There is no requirement for you to document your proposal to verify product at the subcontractor s premises but such a plan would indeed be a useful section in any quality plan that you produced. (See also Control of subcontractors in this chapter.)... 

The requirements pertain to your customer verifying product purchased by you either at your supplier or on your premises. Verification of purchased product is normally carried out by the supplier before or after receipt as part of the purchasing process but may also be carried out by the customer. However, due to the standard locating most of the inspection and test requirements in clause 4.10, the receipt inspection requirements are displaced. 

The standard requires that in determining the amount and nature of receiving inspection, consideration should be given to the control exercised at the subcontractor s premises and recorded evidence of conformance provided. The supplementary requirements require the supplier to use one or more of four prescribed methods unless waived bp the customer. 

Within your procedures you need to provide a means of identifying which items have been subject to inspection at the subcontractor s premises and the receipt inspection action to be taken depending on the level of that inspection. In one case, the product may have been accepted by your representative on the subcontractor s premises. In another case, a product from the same batch may have been accepted by your representative but not the one that has been delivered. Alternatively your representative may have only performed a quality audit to gain a level of confidence. You need to specify the inspection to be carried out in all such cases. The standard emphasizes that consideration should also be given to the recorded evidence provided. Even if someone has performed inspection at the subcontractor s premises, if there is no evidence of conformance the inspections are of little value. The fact that an inspection was carried out is insufficient. There has to be a statement of what was checked and what results were obtained and a decision as to whether conformance has been achieved. Without such evidence you may need to repeat some of the inspections carried out on the subcontractor s premises. 

The subcontractor records that are delivered to you should form part of your records. However, the controls you can exercise over your subcontractor s quality records are somewhat limited. You have a right to the records you have paid for but no more unless you invoke the requirements of this clause of the standard in your subcontract. Your rights will probably only extend to your subcontractor s records being made available for your inspection on their premises therefore you will not be able to take away copies. It is also likely that any subcontractor records you do receive are copies and not originals. Before placing the contract you will need to assess what records you will require to be delivered and what records the contractor should produce and retain. 

It is normal practice in insurance for surveyors employed by the insurance company or the insurance broker to inspect premises that are to be insured and prepare reports for the underwriters. A major part of the survey report is an assessment of the quality of the fire protection relative to the level of hazard in the premises. Obviously, the business being carried on has a considerable influence on the risk of fire or explosion. 

The Competent Authorities are obliged to appoint Inspectors for checking that all activities associated with clinical trials are conducted in compliance with the regulations. The inspectors can inspect any sites concerned with the clinical trial, particularly the trial site (GCP), the manufacturing site of the investigational medicinal product (GMP), any laboratory used for analyses in the clinical trial (GLP), and/or the sponsor s premises. 

Quality Management Personnel Premises and Equipment Documentation Production Quality Control Contract Manufacture and Analysis Complaints and Product Recall Self Inspection... 

Laboratories wishing to claim GLP compliance are normally registered with Competent Authorities who issue statements of compliance following successful periodic inspections of the premises. 

Regulatory functions include licensing of persons, premises and practices, inspection of pharmaceutical establishments, product assessment and registration, QC, control of dmg promotion and advertising and monitoring of ADR. 

When explanation is requested at intermediate points in a session. Just the reasoning for the current decision tree is presented. By asking for elaboration, the user can inspect the reasoning underlying the current rule. Elaboration of the corona decision above would yield descriptions of the lines of reasoning which determined the premises that the oil temperature was moderate, that the concentration of H2 was medium, etc. Elaboration may be repeated until the user is satisfied or until all the steps have been examined. 

Based on the verification process already defined, upon receipt of purchased material the laboratory inspects and verifies that the received materials conform to the purchase requirements. When the verification is made at the supplier s premises there is a need to make arrangements for such verification and for a definition of the method for the release of products. 

Before the market launch of the product, regulatory authorities will inspect the production premises and processes to ensure that everything complies with the licence application and GMP. GMP must be maintained throughout the production cycle, including, where required, suppliers and also the distribution chain. In fact. 

In summary. Directive 86/609/EEC requires the premises in which animal research is undertaken and persons conducting such research, to be subject to local registration and inspection and imposes limitations upon the breeding and supply of experimental animals. There are specific provisions regarding the care of experimental animals, including, for example, minimum caging and temperature requirements. As a Directive, 86/609/EEC required implementation... 

Subject to any arrangements which may have been concluded between the Community and third countries, the Commission, upon receipt of a reasoned request from a Member State or on its own initiative, or a Member State may propose that the trial site and/or the sponsor s premises and/or the manufacturer established in a third country undergo an inspection. The inspection shall be carried out by duly qualified Community inspectors. 

Firefighters must do inspections of any buildings, hospitals, factories, and schools in their area. They check the premises for any violations of fire safety regulations. All of the following should be checked for violations EXCEPT the... 

Locate the building manager and inform him or her that you are here to inspect the premises. 

The inspection of a building is almost complete. What is the last thing a firefighter should do before leaving the premises ... 

This time you have been asked what the last step in the inspection is. The key word is last. The last step given in the procedure is to visually examine the premises for improper wiring. Thus, the answer is choice a. 

As shown in Tables 6-8 the Indian GMP regulations consists of eight parts I, IA, IB, IC, ID, IE, IF, and II. Part I covers the general requirements of GMP. It is divided into 29 chapters, which deal with the requirements for personnel, premises, equipment, sanitation, production and process controls, materials, documentation, quality management, validation, reserve samples, recalls, complaints, and self-inspection. Parts IA to IE cover specific requirements for the manufacture of different dosage forms regarding premises, equipment, and methods. Part IA deals with the require-... 

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