Essential Insights Into Pharmaceutical Product Release, Part 2

The second installment of this two-part blog series focuses on optimizing the product release process in pharma, strategies for effective planning, crucial quality management system (QMS) elements, setting appropriate product specifications, leveraging electronic systems, and the role of contract manufacturing organizations (CMOs) in the release process. You can read part one here.

Introduction

How do we optimize the pharma product release process? The pharmaceutical product release process encompasses multiple inputs from across the organization. In part one of this article we discussed the importance of pulling from data sources including raw material and component data, manufacturing, in-process testing, instruments/equipment/software, personnel training, final release inspection and testing, and more. We also discussed the importance of considering product release early in the development process. The question is, how do we minimize the time and expense associated with drug product release?

Effective Planning

Don’t underestimate the importance of planning and communication in pharmaceutical product release. When pharma companies create their initial concept documents, they are already planning how they will sell and market the product. Similarly, pharma companies need to establish how they will efficiently release drug products to avoid unnecessary delays, spoilage, and scrapped products. Early consideration also ensures that the appropriate records are created at the time of manufacture.

Create clear pharma product release specifications that define what is needed for product release, not what is nice to have. These specifications should complement your validation documentation and your process characterization (process understanding). For example, clearly understanding and defining process limits can help companies quickly determine if a parameter is truly out of specification and identify process trends and drift.

By planning for interruptions or changes to manufacturing spaces, cleanrooms, equipment, instrumentation or software in advance, companies can avoid costly deviations during the GMP manufacturing process that will then need to be reviewed and approved during product release. Unplanned deviations consume time and resources and can delay the actual release of product as well as compromise the good manufacturing practice (GMP) compliance of a given batch.

Effective pharma product release planning includes:

• Creating clear release specifications.
• Identifying critical control points.
• Developing forms and templates for release records.
• Planning for manufacturing changes and revalidations.
• Facility and equipment changes.
• Robust process characterization and validation.

Electronic Systems (eQMS and EBR)

An electronic batch record (EBR) that works with an electronic quality management system (eQMS) can be extremely useful in streamlining the pharma product release process. With integrated eQMS and EBR systems, data can be pulled from across the organization in a matter of minutes. For example, companies can easily track training records for an individual performing a GMP task or set alerts when an operator is out of compliance with training requirements that must be met for pharma regulatory compliance to be upheld. Similarly, data from supplier quality, maintenance, and testing laboratories can also be collected and reviewed from a single source to support a specific batch during the pharma product release process.

Key takeaways for pharma QMS/EBR integration:

• Efficiently pulling records from multiple sources into one interface.
• Training record integration with batch release information.
• Quality investigations/corrective action/preventive action (CAPA) tagging for impacted batches.
• Simplified access to supplier qualification information.

Using Pharma Contract Manufacturers

Partnering with pharma contract manufacturers, including CMOs and contract development manufacturing organizations (CDMOs), is a great way to efficiently manufacture products. However, it is important to remember that the pharma contract manufacturer is not responsible for product release.

As section 211.22 of 21 CFR Part 211, “Responsibilities of quality control unit,” states: “There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company” [emphasis added].

Given the routine and structured nature of pharma product release, it can be an ideal activity to outsource to a third-party quality consulting group like BatchWize. Third-party quality contractors are a low-cost alternative to in-house staffing and can provide specialized resources trained specifically for reviewing product release records.

When using a pharma contract manufacturer, be sure to consider these helpful pharma product release tips:

• Create a formal pharma product release program where there is a handoff between the CMO and the license holder.
• Establish a quality agreement so all roles and responsibilities are clearly defined.
• The license holder (or manufacturer of record) should have final approval of all batches.
• Set timelines for responses and documentation requests.
• Use third-party quality reviewers if you don’t have the internal staff for a thorough quality review of your batches.

If nonconforming or adulterated products are released to the marketplace it is the manufacturer, not the CMO, who is held responsible by the U.S. Food and Drug Administration (FDA).

Summary

If you want to optimize your pharma product release process, focus on planning and communication including specification development and process characterization. Using a CMO is a great way to manufacture products, but remember that pharma product release ultimately lies with the manufacturer/license holder. Using an eQMS or EBR is a great way to collate data from multiple sources and ensure that the appropriate GMP records are easily available for a particular batch. It is also a good way to ensure that all essential quality events are addressed before completing pharma product release. If you are looking for assistance with developing a pharma product release program or need a third party to review product release records, reach out to an experienced quality consulting group that specializes in pharma product release.