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503B Outsourcing Facility validation package of protocols.



Validation Online has been supplying interactive validation protocol templates for over sixteen years. These templates are widely used throughout the Bio-Med industries and carry our unconditional guarantee of being fit-for-purpose.

From 2013 the FDA designated 503B Dispensing Pharmacies as “Outsourcing Facilities” that may produce large batches of regulated product with or without prescriptions to be sold to healthcare facilities. 503B approved facilities are required to maintain full compliance with current good manufacturing practices (CGMP), I.E. the ensuing steps for dispensing, mixing or blending, filtration, compression or filling, container closure system (CCS) filling, coating, polishing, device filling, and packaging of a drug product must occur under a strict CGMP systems of controls.
503B-Dispen-Pharmacy-IQ-Issue-3
$118.00
11300020
This Installation Protocol defines the responsibilities and the procedures that must be complied with to ensure that the Installation Qualification of this equipment is successfully completed. The successful completion of this protocol will verify that this installation is in compliance with the Company Quality Standards and the cGMP requirements as defined in the United States Code of Federal Regulations, Title 21, Parts 820, 210 and 211, and the European Union – Good Manufacturing Practice Directive 91 / 356 / EEC, (EU-GMP).
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503B-Dispen-Pharmacy-OQ-Issue-3
$125.00
11300025
The System Tests / Inspection protocol sheets, 4.1 to 4.12 are already in the generic OQ. Do include all of these sections, even although you may know that that one or two are not applicable. It lets the regulator know you are aware of these test/inspection requirements. If they are not required, then insert comments to this effect and sign them off. Addition Test Sheets (4.12 to 20) are available in the document store (along with 1 to 11), and can be separately bought and downloaded. These additional test sheets, when required, should be independently and consecutively pasted in after 4.11. The document should then be checked for blank pages, chapter sequencing, and numbering.
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503B-Dispen-Pharmacy-VMP-Issue-3
$135.00
11300001
The objectives of this Validation Master Plan are to provide documented instructions regarding the Validation and Continued Good Manufacturing Procedures (cGMP) that are used by llllllllll in their facility in mmmmmmmmmm, during the manufacture, packaging, testing, storage, and distribution of regulatory controlled product and to verify that these operations are carried out in accordance with the rules and guidance given by 21 Code of Federal Regulations 21 Part 11, 210, 211, 820, EU GMP, and WHO.
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503B-Dispen-Pharmacy-VP-Issue-3
$110.00
11300008
The purpose of equipment validation is to establish by the use of documented evidence that the equipment can and does consistently operate in accordance with its design specification and deliver the performance specified in the User Requirements Specification. The installation, maintenance, and operation of the equipment must also conform to all the relevant requirements as detailed in the cGMP regulation. The validation of each piece of production equipment will entail executing pre-approved specified protocols, the execution of these protocols must deliver the documented evidence required.
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503B-Dispen-Pharmacy-URS-Issue-3
$112.00
11300010
This User Requirements Specification defines the requirement for this equipment and the function of this equipment in the production, testing, storing and or handling of company's product that is the subject of regulatory compliance rules and regulations. The use of this URS will ensure that the equipment is specified, purchased, installed, operated and maintained in accordance with the Company Quality Standards and the cGMP requirements as defined in the United States Code of Federal Regulations, Title 21, Parts 820, 210, 211 & 11, and the European Union – Good Manufacturing Practice Directive 91 / 356 / EEC, (EU-GMP).
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503B-Dispen-Pharmacy-DQ-issue-3
$115.00
11300012
This document contains a generic Design Qualification (DQ) (Pages 4 to 28) along with instructions, in the form of an SOP (pages 1 to 3), on how, using the SOP sheets, to change this generic DQ into a bespoke DQ for the equipment you require to validate. Once these instructions are completed and the generic DQ has been fully populated, the SOP pages 1 to 4 are deleted and the DQ becomes a stand-alone bespoke document.
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503B-Dispen-Pharmacy-PQ-Issue-3
$120.00
11300027
This PQ must be executed using approved production documentation. Any inconsistencies or errors discovered must bring the PQ to a halt. The PQ must not be restarted until the corrected approved documentation is available for use by the operators. Any performance tolerances that have or are to be adjusted to compensate for the placebo differing in action / reaction to the actual product, must have a fully documented and validated rationale.
Quantity
503B-Disp-Pharma-Validation-Pack
$799.00

From 2013 the FDA designated 503B Dispensing Pharmacies as “Outsourcing Facilities” that may produce large batches of regulated product with or without prescriptions to be sold to healthcare facilities. 503B approved facilities are required to maintain full compliance with current good manufacturing practices (CGMP), I.E. the ensuing steps for dispensing, mixing or blending, filtration, compression or filling, container closure system (CCS) filling, coating, polishing, device filling, and packaging of a drug product must occur under a strict CGMP systems of controls. Validation Online has now released a package of validation documents designed specifically for validating such a 503B Dispensing Facility. The package consists of:-

VMP – VP – URS – DQ – VRA – IQ – OQ – PQ      503B-Dispen-Pharmacy-Validation-Pack $799.00


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503B-Dispen-Pharmacy-VRA-Issue-3
$125.00
11300014
It is required in this document to assess each piece of production equipment and to determine what level of validation is required to verify that the equipment; All equipment that has been subjected to the questionnaire (Table A) and shown at least one positive answer requires to be validated. However, it is not practical or appropriate that they should all be subjected to the same standard of validation. The outcome of the Risk Impact Assessment (VRA) must; therefore, be used to select the scope of validation that is appropriate for the equipment being assessed.
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