PQLI Guide: Part 4 - Process Performance & Product Quality Monitoring System
Published: June 2013
Pages: 80
The ISPE PQLI® Guide: Part 4 – Process Performance and Product Quality Monitoring System provides practical how-to guidance with examples of technical and scientific methodology for adopting a process performance and product quality monitoring system (PP&PQMS) in line with the expectations of ICH Q10, Pharmaceutical Quality System.
By establishing a PP&PQMS, your company can improve opportunities to:
- Maintain compliance with global regulations
- Improve confidence that a process runs as intended
The Guide introduces the role of Quality Steward as an owner of product quality. Responsibilities of the role are discussed for this new concept emerging from industry.
This PQLI Guide is relevant for:
- New and existing products
- Small and large molecule
- All phases of product lifecycle, from development through product discontinuation
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