The store will not work correctly when cookies are disabled.
Due to scheduled maintenance, select standards and products will be unavailable for purchase beginning Thursday, December 4, 2025, at 12:00 a.m. Eastern (GMT-5) ending Friday, December 12, 2025 at approximately 12:00 p.m. Eastern (GMT-5).
Using Artificial Intelligence (AI) on ASTM standards and related intellectual property is prohibited. Violations will result in suspension of access.
Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and ControlE2475-10ASTM|E2475-10|en-USStandard Guide for Process Understanding Related to Pharmaceutical Manufacture and ControlStandardE2475 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control>newBOS Vol. 14.01 Committee E55
$86.00
In stock
Scope
1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using quality by design (QbD) (Juran, 1992; FDA/ICH Q8). The framework is applicable to both active pharmaceutical ingredient (API) and to drug product (DP) manufacturing. High (detailed) level process understanding can be used to facilitate production of product which consistently meets required specifications. It can also play a key role in continuous process improvement efforts.
1.2 Process Analytical Technology (PAT) is one element that can be used for achieving control over those inputs determined to be critical to a process. It is important for the reader to recognize that PAT is defined as:
Domestic orders are delivered via United Parcel Service (UPS) or United States Postal Service (USPS). Transit
times average 3 to 5 business days. Please be aware that UPS will not deliver packages to Post Office Boxes.
International orders are delivered via courier post services which can be either a postal service, courier
service, or a combination of both. Standard Service is untraceable. Please allow 4-7 weeks for delivery.
Please be aware that carriers will not deliver packages to Post Office Boxes. Because of the variability of
customs processes and procedures in different countries, ASTM International cannot guarantee transit times to
international destinations. Customs duty and taxes are the responsibility of the consignee.
Shipping & Handling charges follow the rate schedule, below:
Order Total
Shipping & Handling Fee (US Domestic)
Up to $50.00
$18.72
$50.01 to $100.00
$20.80
$100.01 to $150.00
$29.52
$150.01 to $250.00
$39.09
$250.01 to $500.00
$56.25
$500.01 to $750.00
$76.42
$750.01 to $1000.00
$93.15
$1000.01 to $1500.00
$121.27
$1500.01 to $2500.00
$158.38
$2500.01 to $4999.00
$209.04
$5000.00 to higher
FREE
Order Total
Shipping & Handling Fee (International)
Up to $50.00
$68.72
$50.01 to $100.00
$70.80
$100.01 to $150.00
$79.52
$150.01 to $250.00
$89.09
$250.01 to $500.00
$106.25
$500.01 to $750.00
$126.42
$750.01 to $1000.00
$143.15
$1000.01 to $1500.00
$171.27
$1500.01 to $2500.00
$208.38
$2500.01 to $4999.00
$259.04
$5000.00 to higher
FREE
Shipping and Handling charges are approximate. Additional charges may be incurred if your order requires multiple shipments. This does not apply to complete sets and sections.
