Application in practice
When it comes to applying the regulation at company level , the drug and the biologic must follow the existing applicable sections of cGMPs ( Parts 210 and 211 and 600- 680 respectively ), while the device constituent must follow the applicable sections of the Quality Systems Regulations for medical devices ( Part 820 ). “ If there is any conflict or ambiguity when you are working in situations where these regulations seemingly overlap , what we are looking for is the ‘ most specifically applicable ’ regulation ,” Uribe said . The constituent parts of a combination product retain their regulatory status even after they are combined , and the cGMP requirements that apply to each of them continue to apply throughout their lifecycle . Organisations have two options to meet their compliance requirements . The first is to comply with all parts of the relevant cGMP requirements for each constituent of . However , Uribe said , “ as we look across our organisation and our manufacturing and compliance landscape , we find that it is very rare that any one organisation is licensed to meet all of those requirements ”. Alcami itself takes the alternative , streamlined approach , in which it complies with a primary set of
Laboratory at Alcami ' s Research Triangle Park site
requirements for one constituent part and with a specific sub-set of the regulations applicable to the other ( s ). Figure 1 gives an outline of some of the key considerations .
Company case study
Currently , Alcami is producing a single entity product , a prefilled syringe , at its steriles facility at Research Triangle Park , North Carolina . To do this , it needed to review and incorporate some applicable elements of Part 820 . The company , Uribe added , is not currently working with any type of software , so installation and servicing was not applicable in its implementation plan . The initial focus in this project , said Brian Dillion , who joined the company as VP of regulatory affairs and QA in June 2020 , was implementing a quality management system compliant with the requirements for a drug-device combination product . Alcami already had established quality systems in place specific to drug product manufacturing in accordance with 21 CFR Parts 210 and 211 , so it first turned to the regulations specific to devices . These included management responsibilities , design controls , purchasing controls , and corrective and preventative actions “ The next stage will be to focus on augmenting quality management systems in support of other types of combination products , starting with co-packaged and cross-labelled products ,” Dillion said . “ Our future goal is to be fully compliant with ISO 13485 and the EU Medical Device Regulations .” For each section of the regulations that had to be integrated into its quality management systems , Alcami identified teams from various different internal functions and appointed a leader an executive sponsor to each . These met on a weekly basis for about six months . The basic plan for each team began with creating a ‘ SIPOC ’ ( Supplier , Inputs , Process , Outputs , Customers ) to help them to understand each of these elements and the required linkages within the organisation . The next goal was to identify future state process mapping and where the company wanted to end up with the new process . “ The meat of the project was to develop and revise SOPs , policies , forms and work instructions ,” said Dillion . “ Here is where you get into the nuts and bolts of what you are actually going to be doing . Once that ’ s done , you develop training materials , finalise your forms and SOPs , and identify the relevant metrics to measure against the new process to make sure it works as you expected it to .” Dillion shared an example of CAPA process optimisation in one team ,
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