How to implement a robust Quality Risk Management Program
In today’s pharmaceutical industry and increasing globalisation of pharmaceutical supply chains, the supply chain often extends across multiple transportation routes and regulatory jurisdictions. It may include sourcing pharmaceuticals from outside of the EU/EEA for distribution within the EU/EEA, or sourcing pharmaceuticals from within the EU/EEA for global distribution. With this evolution, focus on GDP has increased. This article reviews and summarises findings and citations from the MHRA and FDA in relation to GDP. MHRA The MHRA have recently released a report of the GDP inspection deficiency data for 2016. The full report can be accessed here and provides good insight into types of deficiencies cited in 2016. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/667494/GDP_2016_Deficiency_data.pdf There were 1428 GDP inspections carried out by MHRA in 2016. The report is based on a sample of approximately 10% of inspections spread across the wide range of business models (e.g. MAH, exporters in possession of WDA). Deficiency examples were provided and these will enable industry to perform its own assessment and comparison. Only major deficiencies were detailed. Of the sample examined, the majority of the findings of the top 3 observations were against 1.2 Quality Systems (22%), 9.2 Transportation (13%) and 2.2 Responsible Person (12%). Examples of observations are provided against EU Commission Guidelines on GDP of Medicinal Products for Human Use (2013/C 343/01). For example:
- EU GDP Chapter 1 Quality Management
“The quality system did not describe the processes for procurement, holding and supply of medicinal product without a marketing authorisation in the EEA.” “There was no formal process for review of outsourced activities including review of written contracts. Some of the written contracts with 3rd party services providers for storage and distribution were out of date.”
- EU GDP Chapter 2 Personnel
“The RP was not able to demonstrate sufficient knowledge of the GDP activities to be carried out and the procedures to be performed to ensure the licence conditions are being complied with.” “There was no formal training in place for the Responsible Person, demonstrating his ongoing awareness of and competence in GDP.”
- EU GDP Chapter 9 Transportation
“There was inadequate reassurance that a robust process was in place assessing the need for temperature controls for ambient storage medicinal products across full range of the company’s transport arrangements, including third party distribution services”. “The site utilised uncontrolled ambient transportation for customer delivery with no risk assessment or definition of responsibilities with customers.” FDA Good Distribution Practice and its respective GDP Guidelines are certainly a hot topic in the EU and states. From the FDA perspective, this is mainly based on
- 21CFR Sec. 211.56 “Sanitation” where it says that “Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition. Any such building shall be free of infestation by rodents, birds, insects, and other vermin.”
- Subpart H “Holding and Distribution”. And this also includes warehouses and storage facilities, as the following excerpts from recent Warning Letters show:
The following excerpts from recent Warning Letters show the types of deficiencies being cited by the FDA: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/default.htm
- Quality System
“During our inspection, we found your quality unit did not approve your written standard operating procedures (SOPs) for numerous critical processes, such as quality unit responsibilities, (…), material quarantine, product distribution, (…), product return, (…), raw material testing, …”
- Premises:
“Our investigator documented copious amounts of unknown black, mold-like material on the floor and walls of warehouse #2. In addition, our investigator observed standing water on the floor and live insects at the entrance of the same warehouse.” “Your firm failed to keep the buildings used (…) free of infestation by rodents, birds, insects, and other vermin (…) throughout the warehouse, around both raw materials and finished drug products.”
- Receipt of medicinal products
“Your firm receives drums of […] raw material from your supplier without any identifying labels“. “When our investigator asked for a list of your critical raw materials and your sampling requirements, you told our investigator that you had no written procedures for testing and sampling incoming materials. Instead, you explained, your warehouse employees accounted for incoming raw material handling, sampling, and testing ‘in their heads’.”
- Inspection management
“You delayed FDA’s access to the warehouse and limited FDA’s inspection by removing the drums before our investigators could inspect them.” It is clear that those playing a role in the pharmaceutical supply chain must comply with GDP requirements, therefore, the service providers such as transportation companies and the logistic service providers need to gain a good understanding of what is required to be able to provide appropriate service to their clients. If you would like further information to assist your organisation, please contact us at +353 1 846 47 42 or contactirl@pharmalex.com.
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