Manufacturers’ checklist for DSCSA compliance
DSCSA compliance in a supply chain is achievable with the combined efforts of all the participants- the manufacturers, the wholesale distributor or the warehouse manager, and the dispenser. While each of them has to maintain compliant standards by deploying software and traceability solutions, manufacturers specifically have to ensure that they adopt the DSCSA best practices to the hilt so that they are approved and licensed under the DSCSA to be attached with the Look-up Directory (LD) to be referred during the VRS process. Some of their key responsibilities also include serialization requirements at every stage in the pharma supply chain, which is an important requirement under the FDA ambit.
As per the FDA, manufacturers are required to adhere to the Current Good Manufacturing Practice (CGMP) regulations. This requires regulations for drugs containing minimum requirements for the methods, facilities, and controls used in the manufacturing, processing and packaging of drugs. The regulation ensures that the product is safe for use and that it has the ingredients and strength it claims to have.
For the purpose, FDA assessors and investigators determine whether the firm has the necessary equipment, facilities and the ability to manufacture the drug it intends to the market. To discuss broadly, the FDA ascribes eligibility requirements for manufacturers to be eligible for the DSCSA licensure in its Code of Federal Regulations (CFR) in Title 21. The pharmaceutical or drug quality-related regulations appear in several parts of Title 21, including sections in parts 1–99, 200–299, 300–499, 600–799, and 800–1299. They have been segregated into:
- For FDA approval to market a new drug.
- Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs.
- Current Good Manufacturing Practice for Finished Pharmaceuticals.
- 21 CFR Part 212. Current Good Manufacturing Practice for Positron Emission Tomography Drugs.
- Biological Products: General.
Any issue with compliance under these categories will call for branding the drugs as ‘illegal’ ‘suspect’.
DSCSA compliance: Manufacturers and contract manufacturers
The collaboration between manufacturers and contract manufacturers has increased the complexity of the supply chain. Both the entities have to manage a large number of partners with varying processes, standards and information-sharing arrangements. DSCSA has guided the two participants to maintain protocols while sharing information so that drug visibility is not compromised at any point in time. To speak more clearly, here are the few things that the entities have to maintain between themselves:
Communication: The T3 information is an important form of data sharing that a manufacturer has to maintain across all the stakeholders in the supply chain. However, maintaining the same with the contract manufacturers is extremely important because, at the end of the supply chain, the integrity of the product will lead to the primary manufacturer alone. Consistent information sharing helps in reducing misunderstandings between entities. These pieces of information have to be shared in master data repositories that are cloud-based and can be accessed by anyone in the supply chain when need be.
Planning: The solutions and software that are required to maintain the understanding between the two stakeholders are important to be planned in time. Some of the other things that need to be in place before engaging with a manufacturing contract are the deployment of labelling and packaging equipment, updates to computer systems hardware, software and other technology assets, training and education of employees.
Manufacture- The compliance factors
DSCSA mandates the manufacturer to successfully define the product from conception to production and control should be exercised over all the changes. Additionally, quality and manufacturing processes and procedures and changes to them must be defined, approved and controlled. Responsibility should be established for designing and changing products. A proper documentation process, controls and changes to these processes will ensure that sources of variability are defined. The document shared by manufacturers should include:
- The resources and facilities used
- The different procedures to carry out the process
- Identification and control of the variables
- Validation activities
- Quality control measures taken
- The data collected
- Monitoring and appropriate controls for the products and the processes
- Record discrepancies and manage requests within 24 hours of the verification request
The factors discussed above are few of the pre-requisites that manufacturers have to fulfil to be eligible to operate in a drug supply chain ethically and get the DSCSA license. Nevertheless, these very factors ensure the ease-of-operation of an end-to-end supply chain process while staying within the premises of DSCSA guidelines.
[Also Read| Pharmaceutical Track and Trace: Sharing the Right Data for a Competent Supply Chain Management]
The Manufacturer: Ease of DSCSA compliance
As already pointed out, the manufacturer has the highest stakes in the integrity of a drug. So, if the counterfeit does infiltrate in between, the manufacturer would be the first to be questioned. The protocols that have been mentioned above are to give the readers a brief idea about the importance of this stakeholder. And, while we say that, we also realize the burden of compliance best practices on the manufacturer that he struggles with on an everyday basis. TrackTraceRX, with its modern traceability solution designs, based on the principles of RapidRX and API-first design, finds an easy solution to abide by the protocols. For instance,
For data sharing, our AR-enabled multiscanners help in capturing and storing the information collected from the GS1 serial numbers on the drug consignments. Manufacturers can record real-time information with the help of a smartphone and the TrackTraceRX app, without even having to open the pallets or the packages. These mobile-edge multiscanners also help in gathering information and storing them in the central repository or the master data that is flexible and expansive, allowing stakeholders to store information for 6 years or more (another requirement by the DSCSA). The API-first approach behind the solutions provided by the traceability partner enables ease of communication between two varied frameworks, without any investment in a separate IT infrastructure. Moreover, the software can be easily downloaded in even traditional framework without tampering with its operational basics, thus saving money, time and the need for training professionals to handle the tool.
DSCSA audit: Auditing report whenever drugs exchange hands is a crucial mandate by the FDA, which ensures that only authentic medicines are being circulated in the supply chain. Stakeholders are required to fill close to 23-pager audit report every time a shipment is done. This report comprises all the T3 information shared and stored by the stakeholders, apart from other information about the make of the medicine. It is required to be filled and sent for FDA auditing, especially in the VRS stage, within 24 hours of reporting a suspect, after consulting with the manufacturer brand. For manufacturers, such information request comes in thousands from different distributors every single day, making it impossible to handle them manually or with single scanners. AR-enabled multiscanners not just help in insta-verification within minutes, turning over results for thousands of packages in a matter of hours, allowing both the ends of the transaction to get a breather in the entire process and the scope to concentrate on other important paperwork.
Drug visibility: TracktraceRX traceability suite is one of the finest innovations of TTRX, enabling easy management and location of a medicine. Used for the VRS or the saleable returns, this suit does not require any third-party intervention to verify or locate a product in the returns stage and easily handles authentication requests between the manufacturer and the distributor. Approve, reject or destroy, this suite has all the details about the saleable returns drugs and their location. Also, they can instantly connect with the look-up directory, also a data repository of manufacturers, to drive the authentication process of the medicines, thus assuring DSCSA compliance both at the manufacturers’, the distributors’ and the dispensers’ stage. It is noteworthy how the look-up directory functions as a premise to decide whether or not a manufacturer is DSCSA compliant or not; Because unless it fulfils all the requirements of the regulatory body and gets a compliance license, the manufacturer will not be included in the LD.
Ease of supply chain processes is just the first step in empowering the DSCSA to ensure that only authentic medicine reach the end-users. The pharmaceutical industry is evolving by the day to achieve much more beyond DSCSA compliance. From manufacturers to the other stakeholders in the supply chain, everyone is aiming for compliance that adds business value too. The day is not far when the otherwise-traditional pharma industry will prove to be the pinnacle of speed and authenticity, with no signs of the counterfeit and fake drugs.
Make TrackTraceRX your knowledge and solution partner and get an in-depth understanding of how the compliance process functions and what is the future of traceability in the future. For more information, you can also go through the articles below:
[DSCSA compliance: Here’s what your supply chain should have at the end of Nov 2023 deadline]
