The US Food and Drug Administration proposed changes to existing pharmaceutical manufacturing regulations over the past year. The FDA Commissioner put forward several statements expressing the agency’s view on redeveloping regulatory approaches to managing drug manufacturing process controls. New laws will create new standards for generic drugs, data controls and sterility requirements, but the most comprehensive change will be more clearly defined obligations for outsourced pharmaceutical manufacturing facilities.
Pharmaceutical preparation contract manufacturers represent an integral part of modern compound drug supply chains as surges in both demand and production expenses create the need for outsourcing at the assembly stage. However, past incidents involving tainted drug products originating in outsourced facilities have caused the FDA to reconsider the level of enforcement that must applied to pharmaceutical manufacturing contractors. This along with the other proposed draft guidance represent a new shift in drug regulations that will stress the abilities of existing process control systems, such as Enterprise Resource Planning (ERP) software solutions.
Here are the new pharmaceutical manufacturing regulations being proposed by the FDA, and how a modern ERP will enable you to fulfill them:
1. Pharmaceutical Preparation Contract Manufacturing
The proposed FDA regulatory changes reflect the growing importance of contract manufacturers in an expanding pharmaceutical value chain that must outsource stages of production to maintain ROI. The new rules are similar to (but expand upon) those already in place for other process manufacturers regarding the key standards that must be reviewed for final products meant for human consumption:
Compounds drugs produced at 503B outsourced facilities must consistently demonstrate the standards established by the FDA for these factors. A manufacturing ERP must be able to track these components as they as they are applied for the additions in the revised regulations.
Current Good Manufacturing Practices (CGMP) establish process control procedures that are presently accepted by the FDA as industry best practice. Manufacturers must follow these at their discretion and remain aware of changes that may occur after review by the agency. The new guidance will expand upon the obligations of 503B outsourced facilities to include better controls for ensuring final products are safe for human use.
CGMP for pharmaceutical manufacturers provide several guidelines for maintaining bulk drug components, from ingredient storage and transport to the level of human contact involved. All material resources used in compound drugs must be reviewed and catalogued according to individual characteristics so as to ensure proper management for formulation, labeling, etc., to avoid any form of product contamination.
Final Product Sterility
The primary concern of FDA-mandated best practices for compound drugs is to any final products which have been tainted from entering the supply chain. To that end, pharmaceutical CGMP dictate process controls for confirming drug product sterility as well as removing pyrogens that may induce fever (depyrogenation). Everything from the outsourced facility’s design to personnel attire to equipment must be sterile to be involved in production and control systems must be implemented to allow for consistent sanitation.
The new regulations do not only apply to domestic outsourcing facilities, but also to contract pharmaceutical manufacturers based overseas. The FDA maintains several foreign offices within countries where outsourced compound drug manufacturing occurs to allow them to enforce compliance on products intended for US citizens. A Chinese producer of an ingredient found in a recalled product has already come under scrutiny of the agency, demonstrating their commitment to enforcing compliance at an international level.
2. Pharmaceutical Manufacturing Facility Data Integrity
“Data integrity” as it applies to CGMP represents the veracity of information recorded on existing process controls that pertain to regulatory practices. This encompasses the accuracy of the data as well as its comprehensiveness – it must be consistent and reflect everything involved in processing. ERP systems for compound drug manufacturers need to be able demonstrate the ability to manage this information and present visibility into activities on demand.
Production and Control Review
FDA-regulated best practices require process manufacturers to be able to review their procedures, as well as redundant controls implemented to protect against those procedures failing. The data integrity guidance induces imposes a greater requirement for more accurate control data for the both the manufacturer’s and the agency’s evaluation.
An important purpose of the process control records obligations is to ensure that tainted products can be traced back to failures within the system or user error. Workflows must be tracked and validated, with audit trails accounting for every action within the outsourced facility.
3. Generic Drug Manufacturing
The US has recently been experiencing a shortage of affordable generic drugs, including potentially life-saving intravenous substances meant for hospital use. Lack of competition and commercial incentive have helped lead to this deficiency, but the FDA is still enforcing stringent requirements for contract manufacturers using bulk substances to produce generic drug products.
Universal Generic Drug Standards
In addition to enabling competition within the market by preventing larger brands from engaging in monopolistic practices, the FDA is also attempting to promote the adoption of a universal standard among international regulatory agencies generic drug compounding. If this new standard becomes law, pharmaceutical manufacturers will have to incorporate the adjusted formulations into their batch processing.
Affordable Drug Manufacturing Act
Generic drug regulations may become further complicated by the introduction of a new bill by Senator Elizabeth Warren (D-Ma.) that allows the government to intervene even further in the market, including up to producing products that are unavailable or unaffordable. However, it also provides manufacturers increased opportunity to deliver affordable alternatives to existing generic drugs or new products to fulfill a need not addressed by other items on the market.
A Modern ERP Will Allow You to Comply with New Pharmaceutical Manufacturing Regulations
The most important takeaway from the proposed changes to existing pharmaceutical regulations is that the FDA is seeking to impose greater transparency upon manufacturers while still enabling them to meet the current demands of the market. Deploying the right technology system will allow you to fulfill compliance in addition to providing you the ability to plan for and meet this growing demand for pharmaceutical products.
Download our e-book to learn how SWK’s Enterprise Pharmaceutical Preparation bundled solution will solve three of the FDA’s most important requirements.