115 products
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1.0 - Dietary Supplement 21 CFR 111 DefinitionsVendor:1.0 - Dietary Supplement 21 CFR 111 Definitions
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1.0 - Drug Definitions used in 21 CFR 211Vendor:1.0 - Drug Definitions used in 21 CFR 211
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1.2 - Good Manufacturing Practice GMPVendor:1.2 - Good Manufacturing Practice GMP
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1.4 - Product Quality Review PQRVendor:1.4 - Product Quality Review PQR
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1.6 - Good Distribution Practice GDPVendor:1.6 - Good Distribution Practice GDP
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1.7 - Self Inspection via Internal AuditsVendor:1.7 - Self Inspection via Internal Audits
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10.0 - Returned and Salvaged Drug ProductsVendor:10.0 - Returned and Salvaged Drug Products
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10.2 - Outsourced GMP ActivitiesVendor:10.2 - Outsourced GMP Activities
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10.3 - Laboratory SpecificationsVendor:10.3 - Laboratory Specifications
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10.4 - Laboratory OOS Investigation & FormVendor:10.4 - Laboratory OOS Investigation & Form
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10.5 - Laboratory Physical and Chemical TestingVendor:10.5 - Laboratory Physical and Chemical Testing
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10.6 - Laboratory Microbiology Testing OverviewVendor:10.6 - Laboratory Microbiology Testing Overview
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10.7 - Laboratory Stability TestingVendor:10.7 - Laboratory Stability Testing
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10.8 - Laboratory Method ValidationVendor:10.8 - Laboratory Method Validation
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11.0 - Manufacturing OperationsVendor:11.0 - Manufacturing Operations
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12.0 - Packaging and Labelling OperationsVendor:12.0 - Packaging and Labelling Operations
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13.0 - Warehouse Holding OperationsVendor:13.0 - Warehouse Holding Operations
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14.0 - Product Returns HandlingVendor:14.0 - Product Returns Handling
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15.0 - Product Complaints HandlingVendor:15.0 - Product Complaints Handling
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16.0 - GMP Records for SupplementsVendor:16.0 - GMP Records for Supplements
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2.0 - Personnel Qualifications and TrainingVendor:2.0 - Personnel Qualifications and Training
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2.1 - Personnel and Visitor Sickness PolicyVendor:2.1 - Personnel and Visitor Sickness Policy
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2.1 - Production & Quality Management ResponsibilitiesVendor:2.1 - Production & Quality Management Responsibilities
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2.2 - Personnel Hygiene and Dress CodeVendor:2.2 - Personnel Hygiene and Dress Code
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3.0 - Buildings and Facilities OverviewVendor:3.0 - Buildings and Facilities Overview
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3.0 - Facility Design and ConstructionVendor:3.0 - Facility Design and Construction
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3.1 - Buildings and Facilities - ProductionVendor:3.1 - Buildings and Facilities - Production
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3.1 - Yard and Grounds MaintenanceVendor:3.1 - Yard and Grounds Maintenance
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3.2 - Buildings and Facilities - LaboratoryVendor:3.2 - Buildings and Facilities - Laboratory
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3.2 - Plant Sanitation Policy and SupervisionVendor:3.2 - Plant Sanitation Policy and Supervision
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3.3 - Buildings and Facilities - Holding and DistributionVendor:3.3 - Buildings and Facilities - Holding and Distribution
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3.3 - Cleaning and Sanitizing AgentsVendor:3.3 - Cleaning and Sanitizing Agents
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3.4 - Buildings and Facilities - Pest ControlVendor:3.4 - Buildings and Facilities - Pest Control
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3.7 - Hand Washing Policy and FacilitiesVendor:3.7 - Hand Washing Policy and Facilities
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4.0 - Equipment Design and ConstructionVendor:4.0 - Equipment Design and Construction
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4.2 - Equipment Cleaning and SanitizingVendor:4.2 - Equipment Cleaning and Sanitizing
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5.0 - Specifications and ControlsVendor:5.0 - Specifications and Controls
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5.1 - Representative and Reserve SamplesVendor:5.1 - Representative and Reserve Samples
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5.1 - Supplier Approval and ControlVendor:5.1 - Supplier Approval and Control
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5.2 - Adjustments and ReprocessingVendor:5.2 - Adjustments and Reprocessing
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5.2 - Materials - Receipt and StorageVendor:5.2 - Materials - Receipt and Storage
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More to Discover
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Use code GMP10 at checkout
When you purchase 10 or more procedures or report forms. Only one discount code per order permitted.
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Use code GMP20 at checkout
When you purchase 30 or more procedures or report forms. Only one discount code per order permitted.
FAQs
How and when will I be able to download my SOPs or laboratory test forms?
Immediately after you have successfully completed payment in the shopping cart you will receive an e-mail from us, to the address that you entered, which contains a download link. Open the e-mail on your PC or laptop, click the link to download the procedures and save the files where you need them. There is no time limit on downloading these, the link will not expire, and if you encounter a problem they can be downloaded again. You are responsible for providing a PC or laptop to download and save your files to. We only ask that you use these files only for one business one purchase, and recommend us to others. We are a small team and have website overheads to cover. Many thanks for your support.
What language and format will my SOPs or laboratory test forms be in?
All procedures and test forms are in English and in Microsoft Word to try and give the widest possible access. They are not write protected and are fully editable by you if you want to make changes to format, numbering, content, integrate them into your current format, or add company logos. We are experimenting with various translation apps to be able to offer in other languages.
What happens if I am unhappy with my purchase or I disagree with a section of a procedure?
Unfortunately due to the nature of downloads we cannot offer a refund. We always suggest to purchase one, or a small number of, procedures from us first to see if you are happy with our products. If you see something you disagree with please do amend it, the procedures are fully editable. If you do have a related regulatory observation please do contact us so we can consider amendments. Everyone involved in compliance is continually learning and the focus, opinions, and expectations of regulatory authorities does change constantly. We can offer you a discount on your next purchase if you share these instances and the details with us.
Can I change the currency that I pay in?
Yes you can, the website should recognise your geolocation and offer you prices in your local currency but at the top of the page there is the option to switch between common currencies. We have included a number of different payment options including paypal and credit card.