The FDA and the EU Authorities issued new regulations regarding serialization, which will become effective during November 2018 (US) and February 2019 (EU).
RS Ness, with its QA, Validations and Regulatory divisions, cooperates with several companies in order to implement Global Serialization Program on their packaging lines (both manual and automatic).
The implementation process includes: engineering, budget support, IT, QA, Validation and compliance on serialization (Track & Trace) requirements.
We make sure the validation approach is consistent with the organization and executable at the client’s sites. We help our client to develop a Validation Master Plan and maintain the client with a Global Serialization implementation that includes validation tasks executions, SOP applying, training and implementing regulatory authorities’ guidance. Providing solutions with serialized data exchanges between internal and external (CMO) packaging locations, internal and external (3PL) distribution centers.
1. Implementation of GS1 standards (2D matrix) and the use of EPCIS data for traceability data exchange.
2. Implementation of regulatory requirements (i.e. US Drug Supply Chain Security Act (DSCSA) (1), the European Union (EU) Falsified Medicines Directive (FMD2011/62/EU), China Product Identification, Authentication and Tracking System (PIATS), Korean Pharmaceutical Information Service (KPIS).