White paper: Validation and qualification

In a regulated environment


The qualification of equipment in the pharmaceutical industry is a significant part of quality assurance and is required by law. This white paper provides an overview of how validation and qualification are classified in a GMP1 environment and describes the general approach for qualification with the key steps of DQ2, IQ3, OQ4, and PQ5. The focus is on unit qualification. The white paper also covers the validation of computer-based systems. The white paper is aimed primarily at interested parties who are yet to have looked into the topic of "validation and qualification."

Request the white paper now!

Fill out the form in order to receive the white paper free of charge.

Fields marked with * are mandatory

Salutation Salutation
  • Salutation
  • Mr
  • Ms
  • Diverse
Country/Region * Country/Region *
  • Country/Region *
  • Afghanistan
  • Albania
  • Algeria
  • American Samoa
  • Andorra
  • Angola
  • Anguilla
  • Antigua and Barbuda
  • Argentina
  • Armenia
  • Aruba
  • Australia
  • Austria
  • Azerbaijan
  • Bahamas
  • Bahrain
  • Bangladesh
  • Barbados
  • Belarus
  • Belgium
  • Belize
  • Benin (Dahomey)
  • Bermuda
  • Bhutan
  • Bolivia
  • Bonaire
  • Bosnia and Herzegovina
  • Botswana
  • Brazil
  • British Virgin Islands
  • Brunei Darussalam
  • Bulgaria
  • Burkina Faso
  • Burundi
  • Cambodia
  • Cameroon
  • Canada
  • Cape Verde
  • Cayman Islands
  • Central African Republic
  • Chad
  • Chile
  • China
  • China(Hong Kong)
  • China(Macau)
  • China(Taiwan)
  • Christmas Islands
  • Colombia
  • Comoros
  • Congo
  • Cook Islands
  • Costa Rica
  • Cote d'Ivoire
  • Croatia
  • Cuba
  • Curaçao
  • Cyprus
  • Czech Republic
  • Denmark
  • Djibouti
  • Dominica
  • Dominican Republic
  • Ecuador
  • Egypt
  • El Salvador
  • Equatorial Guinea
  • Eritrea
  • Estonia
  • Ethiopia
  • Falkland Islands
  • Faroe Islands
  • Fiji Islands
  • Finland
  • France
  • French Guiana
  • French Polynesia
  • Gabon
  • Gambia
  • Georgia
  • Germany
  • Ghana
  • Gibraltar
  • Greece
  • Greenland
  • Grenada
  • Guadeloupe
  • Guam
  • Guatemala
  • Guernsey
  • Guinea
  • Guinea-Bissau
  • Guyana
  • Haiti
  • Honduras
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Iran
  • Iraq
  • Ireland
  • Isle of Man
  • Israel
  • Italy
  • Jamaica
  • Japan
  • Jersey
  • Jordan
  • Kazakhstan
  • Kenya
  • Kiribati
  • Kosovo
  • Kuwait
  • Kyrgyz Republic
  • La Réunion
  • Lao People's Democratic Republic
  • Latvia
  • Lebanon
  • Lesotho
  • Liberia
  • Libyan Arab Jamahiriya
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Macedonia
  • Madagascar
  • Malawi
  • Malaysia
  • Maldives
  • Mali
  • Malta
  • Marshall Islands
  • Martinique
  • Mauritania
  • Mauritius
  • Mayotte
  • Mexico
  • Micronesia
  • Moldova
  • Monaco
  • Mongolia
  • Montenegro
  • Montserrat
  • Morocco
  • Mozambique
  • Myanmar
  • Namibia
  • Nauru
  • Nepal
  • Netherlands
  • New Caledonia
  • New Zealand
  • Nicaragua
  • Niederl Antillen
  • Niger
  • Nigeria
  • Niue
  • Norfolk Islands
  • North Korea
  • Northern Mariana Islands
  • Norway
  • Oman
  • Pakistan
  • Palau
  • Panama
  • Papua New Guinea
  • Paraguay
  • Peru
  • Philippines
  • Pitcairn Islands
  • Poland
  • Portugal
  • Puerto Rico
  • Qatar
  • Republic of the Congo
  • Romania
  • Russian Federation
  • Rwanda
  • Saint Barthélemy
  • Saint Christopher (St. Kitts)-Nevis
  • Saint Helena
  • Saint Lucia
  • Saint Pierre and Miquelon
  • Saint Vincent and the Grenadines
  • Samoa
  • San Marino
  • São Tomé and Príncipe
  • Saudi Arabia
  • Senegal
  • Serbia
  • Seychelles
  • Sierra Leone
  • Singapore
  • Sint Maarten
  • Slovak Republic
  • Slovenia
  • Solomon Islands
  • Somalia
  • South Africa
  • South Georgia and South Sandwich Island
  • South Korea
  • Spain
  • Sri Lanka (Ceylon)
  • Sudan
  • Suriname
  • Svalbard
  • Swaziland
  • Sweden
  • Switzerland
  • Syria
  • Tajikistan
  • Tanzania
  • Thailand
  • Timor-Leste
  • Togo
  • Tokelau
  • Tonga
  • Trinidad and Tobago
  • Tunisia
  • Turkey
  • Turkmenistan
  • Turks and Caicos Islands
  • Tuvalu
  • Uganda
  • Ukraine
  • United Arab Emirates
  • United Kingdom
  • United States
  • United States Virgin Islands
  • Uruguay
  • Uzbekistan
  • Vanuatu
  • Vatican City
  • Venezuela
  • Vietnam
  • Wallis and Futuna
  • West Bank/Gaza Strip
  • Western Sahara
  • Yemen
  • Zambia
  • Zimbabwe
Province * Province *
  • Province *
  • Province *
  • Anhui Province
  • Beijing Municipality
  • Chongqing Municipality
  • Fujian Province
  • Guangdong Province
  • Gansu Province
  • Guangxi Zhuang
  • Guizhou Province
  • Henan Province
  • Hubei Province
  • Hebei Province
  • Hainan Province
  • Hong Kong
  • Heilongjiang Province
  • Hunan Province
  • Jilin Province
  • Jiangsu Province
  • Jiangxi Province
  • Liaoning Province
  • Macau
  • Inner Mongolia
  • Ningxia Hui
  • Qinghai Province
  • Sichuan Province
  • Shandong Province
  • Shanghai Municipality
  • Shaanxi Province
  • Shanxi Province
  • Tianjin Municipality
  • Taiwan Province
  • Xinjiang Uyghur
  • Tibet
  • Yunnan Province
  • Zhejiang Province
Branch * Branch *
  • Branch *
  • Pharmaceutical
  • Academia & Governmental
  • Healthcare
  • Food & Beverage
  • Automotive & Aerospace
  • Chemistry
  • Electronics
  • Biotechnology
  • Cosmetics
  • Packing
  • Painting & Coating
  • Building Materials
  • Engineering & Precision
  • Plastics

By requesting the whitepaper, I agree that BINDER GmbH may send me information about offers, promotions, and relevant topics via email. The whitepaper will only be sent after clicking the link in the confirmation email (double opt-in). Unsubscribing is possible at any time.

You can find our data privacy information here.

Content of the white paper:

  • History
  • Good manufacturing practice
  • GMP publications by various organizations
  • Validation
  • Types of validation
  • Qualification
  • Validation of computer-based systems
  • Validated system
  • Trends
  • Conclusion