GMP Regulation Handbook: General, Finished Pharmaceuticals, 21 CFR Parts 210 & 211
Downloads
Regulation Handbook: 21 CFR Parts 210 (General) & 211 (Finished Pharmaceuticals)
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General and Current Good Manufacturing Practice for Finished Pharmaceuticals
The Pharmaceuticalhandbook is used in association with several ISPE training courses:
- GMP Auditing for Quality Assurance Training Course (G07)
- Applying the GMPs (G03)
- Pharma Water Generation USP WFI & Purified Water Training Course (T04)
- GAMP® Basic Principles Training Course (T07)
- GAMP® Part 11 Training Course (T08)
- Practical Application of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems (T11)
- GMP Sterile Pharmaceutical Manufacturing Facility Training Course (T12)
- Clinical Trial Materials Training Course (T13)
- Storage, Delivery and Qualification Pharma Water Training Course (T23)
- Biotechnology Manufacturing Facility Design Training Course (T31)
- GAMP 5®, Annex 11/Part 11 Basic Principles Training Course (T45)
Emerging Economy Publication Discount
ISPE members located in nations with emerging economies* are eligible for a 50% discount on publications from the regular member price. To receive the discount, members must be logged in with their ISPE member account. Contact Member Services at ask@ispe.org for more information or if you have questions about your membership status or this discount program. Discounts do not apply to Accuris (formerly Techstreet) document downloads.
*Based on the World Bank's system for classifying national economies by GNI per capita. Includes low-income, lower middle-income, and upper middle-income economies. To learn more about the World Bank classification system, please click here. Currently includes the following nations, except where international sanctions apply:
- Afghanistan
- Albania
- Algeria
- Angola
- Argentina
- Armenia
- Azerbaijan
- Bangladesh
- Belarus
- Belize
- Benin
- Bhutan
- Bolivia
- Bosnia and Herzegovina
- Botswana
- Brazil
- Bulgaria
- Burkina Faso
- Burundi
- Cabo Verde
- Cambodia
- Cameroon
- Central African Republic
- Chad
- China
- Colombia
- Comoros
- Congo, Dem. Rep.
- Congo, Rep.
- Costa Rica
- Côte d’Ivoire
- Cuba
- Djibouti
- Dominica
- Dominican Republic
- Ecuador
- Egypt, Arab Rep.
- El Salvador
- Equatorial Guinea
- Eritrea
- Eswatini
- Ethiopia
- Fiji
- Gabon
- Gambia, The
- Georgia
- Ghana
- Grenada
- Guatemala
- Guinea
- Guinea-Bissau
- Haiti
- Honduras
- India
- Indonesia
- Iran, Islamic Rep.
- Iraq
- Jamaica
- Jordan
- Kazakhstan
- Kenya
- Kiribati
- Korea, Dem. People's Rep.
- Kosovo
- Kyrgyz Republic
- Lao PDR
- Lebanon
- Lesotho
- Liberia
- Libya
- Madagascar
- Malawi
- Malaysia
- Maldives
- Mali
- Marshall Islands
- Mauritania
- Mauritius
- Mexico
- Micronesia, Fed. Sts.
- Moldova
- Mongolia
- Montenegro
- Morocco
- Mozambique
- Myanmar
- Namibia
- Nepal
- Nicaragua
- Niger
- Nigeria
- North Macedonia
- Pakistan
- Palau
- Papua New Guinea
- Paraguay
- Peru
- Philippines
- Russian Federation
- Rwanda
- Samoa
- São Tomé and Príncipe
- Senegal
- Serbia
- Sierra Leone
- Solomon Islands
- Somalia
- South Africa
- South Sudan
- Sri Lanka
- St. Lucia
- St. Vincent and the Grenadines
- Sudan
- Suriname
- Syrian Arab Republic
- Tajikistan
- Tanzania
- Thailand
- Timor-Leste
- Togo
- Tonga
- Tunisia
- Türkiye
- Turkmenistan
- Tuvalu
- Uganda
- Ukraine
- Uzbekistan
- Vanuatu
- Vietnam
- West Bank and Gaza
- Yemen, Rep.
- Zambia
- Zimbabwe
