RT Journal Article
SR Electronic
T1 PDA Points to Consider: Technical Product Lifecycle Management Pharmaceutical Quality System Effectiveness For Managing Post-Approval Changes
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2017.007575
DO 10.5731/pdajpst.2017.007575
A1 Ramnarine, Emma
A1 Busse, Ursula
A1 Chassant, Franck
A1 Colao, Marcello
A1 Edwards, Julia
A1 O'Donnell, Kevin
A1 Jornitz, Maik
A1 Munk, Morten
A1 Seymour, Melissa
A1 Simianu, Mihaela
A1 Skeens, Lisa
A1 Vinther, Anders
YR 2017
UL http://journal.pda.org/content/early/2017/02/14/pdajpst.2017.007575.abstract
AB The International Council for Harmonisation Quality Guideline 10 (ICH Q10) describes the Pharmaceutical Quality System (PQS), indicating it is intended to apply throughout a product's lifecycle, in conjunction with good manufacturing practice (GMP) requirements, in order to achieve quality in a consistent and reproducible manner. Implementation of an effective PQS is essential for a company to achieve product realization, establish and maintain a state of control, and facilitate continual improvement (1). When changes are made during the commercial life of a product, an effective PQS, product and process understanding, and use of quality risk management should ensure that product quality, patient safety, and adequate supply to patients are maintained; this, according to ICH Q10-Annex 1, should provide companies the opportunity to manage post-approval changes (PAC) with reduced regulatory oversight (1). But what exactly constitutes an effective PQS? And how does it support change management for PACs? This paper intends to answer these questions and guide companies to seize the opportunities outlined in ICH Q10-Annex 1, to manage product and process changes within the PQS, and downgrade the level of regulatory submission required. This is the second of a series of PDA "Points to Consider" papers on technical product lifecycle management; the first paper focused on the technical product lifecycle management strategy including communication and knowledge exchange between Marketing Authorization Holders and Health Authorities.