3 Top Tips for Establishing an Overall Quality System – Beginning to End

The Quality System applies to each step of the supply chain from forecast till deliver and customer satisfaction, including registration process, actual demand, supply, pharmaceutical operations, storage, packaging, transportation, customs, customers, technology and providers.

Dr. Sandra O. Rumiano , Advisor & GMP Expert, WHO (World Health Organization), provides us with an overview of the Quality System and shares her top 3 tips for establishing an overall Quality System. Cold Chain IQ : Please could you briefly outline your role and responsibilities at WHO?

S Rumiano: I'm a GMP expert consultant for WHO, particularly for vaccines area, so I’m convened by WHO for procuring my services in site visits for prequalification purposes, since I’m a contract person of WHO, the Company that’s receiving me, review my resume previous to any visit for acceptance or not. Confidentiality agreements as well as no conflict interest forms are completed and signed before any Mission starts. Once a goal of prequalification is reached, the Company/product is able to supply UN. Just as an example, UNICEF is the world's largest distributor of vaccines for developing countries, providing vaccines for more than half of the world's children in over 190 countries. Cold Chain IQ: What initiatives is WHO implementing to promote quality in the pharmaceutical supply chain?

S Rumiano: WHO has Technical report series Where Recommendations to assure the quality, safety and efficacy of medicines are established . As an example GDP is part of WHO Technical Report Series, No. 937, 2006 in it´s Annex 5 Good distribution practices for pharmaceutical products is included.

WHO Technical Report Series, No.961, 2011, Annex 9 Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products

WHO receives and makes the follow up of any claim regarding the supply of medicines coming from a prequalified supplier, ie broken vials, physical conditions change, etc, It’s an active role.

Cold Chain IQ: What would be your top 3 tips for establishing a Quality System based on ICH Q10? [inlinead] S Rumiano:

Clear commitment of top management/company CEO to determine quality policy and allocate resources Complete involvement of headcount, based on quantifiable, reachable and clear objective definition, according to quality policy. Thorough understanding of the quality system focus on life cycle approach where each step at SC is included To be close to the continuous improvement in the Knowledge management and Quality risk management implementation Cold Chain IQ: What are some of the best practices companies can employ to evaluate the status of their Quality System among their supply chain?

S Rumiano:

Involvement of HQ and managers in quality system Involvement and training on SCM of staff internal audit system external audit system claims , deviations and CAPA plan KPIs (Key Prerformance Indicators), to monitor overall supply chain process. Its use is advisable once the process is under control, implying the assessment of customs facilities, transport and distribution operators, etc. Cold Chain IQ: In your opinion, what regulation(s) do you think will have the biggest impact on the temperature controlled supply chain for pharmaceuticals in 2013?

GDP guidelines that focus on SC USP 35 new GOOD STORAGE AND SHIPPING PRACTICES as well as control chapter EMA proposal GDP under revision for verifying transport routes and conditions in the supply chain will also be considered. Validation Others: IATA guidelines for Perishable Cargo Technical Report 58 of Parenteral Drug Association (PDA) provides guidance to identify, control and assess temperature controlled products supply chain Cold Chain IQ: How has the temperature controlled supply of pharmaceuticals in Central and Latin America evolved in recent years?

S Rumiano:

Central and Latin American regulatory authorities are beginning to include requirements about cold chain and controlled temperature products. No only manufacturers but also transport and distribution operators began to adapt its facilities and system to satisfy them. Companies by greater awareness of the conditions of storage and load distribution and application of qualification and validation tools, greater regulatory requirement, high commitment of the Health Authorities to prevent forgery and theft in the supply chain. Cold Chain IQ: What will be the benefit of attending your training course at the event? What are you looking forward to?

Training & learning Share experiences to identify clear guidelines for assuring supply chain integrity Have Your Say Rate this feature and give us your feedback in the comments section below

3 Top Tips for Establishing an Overall Quality System – Beginning to End

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