Last week’s post discussed contract packager Capabilities. This week, we’re discussing the importance of Quality and the key considerations during evaluation.

QUALITY ASSURANCE

Confidence in your contract packager begins with its commitment to quality. Specialized skills in compliance programs such as calibration, validation, auditing, equipment maintenance and quality management systems should be evident. When selecting a contract manufacturer and packager, the quality checklist should include considerations such as: the contract packager’s ability to provide updates on regulatory requirements, the ability to react to quality issues and partner with the customer, and evidence of the supplier’s continuous improvement programs for quality, manufacturing and packaging.

Multi-Pack Solutions is proud of, and willing to share with its customers, an excellent history of FDA Inspections due to its diligence in maintaining quality systems. During the last three consecutive FDA quality inspections, Multi-Pack Solutions has received no Form 483 observations.

Registrations

Multi-Pack Solutions is supported by a robust quality program that adheres to the highest standards for the U.S. Food and Drug Administration’s Quality System Regulations for Medical Devices (21 CFR Part 820) and for finished pharmaceuticals (21 CFR Part 211).

In-House Chemistry and Microbiology Labs

On-site micro and chemistry labs at Multi-Pack Solutions’ Greenville facility allow timely testing of product material from receipt through shipment. These in-house capabilities ensure the integrity of product handling and testing methods, and provide complete traceability.

An on-site microbiology lab allows fast identification of any manufacturing or packaging challenges that could affect speed to market. Multi-Pack Solutions can perform environmental sampling including surface and air sampling and testing, and can identify microorganisms using gram staining, selective media, biochemical tests and its Biolog identification system.

The company’s micro testing and screening capabilities in compliance with current USP guidelines are listed below:

  • Total aerobic count
  • Total yeast and mold count
  • USP—E. coli screening
  • Pseudomonas aeruginosa screening
  • Salmonella spp. screening
  • Staph aureus screening
  • Candida albicans screening
  • Biolumix rapid methods system (Micro result in two days)
  • Microbial limits preparatory tests; validation
  • Antimicrobial effectiveness testing (Preservative effectiveness)

Multi-Pack Solutions’ in-house chemistry lab features HPLC equipment, GC equipment TOC Analyzers and a new, validated walk-in room temperature Environmental Stability Chamber, as well as Accelerated Environmental Stability chambers.

The in-house proficiencies listed below, along with wet chemistry capabilities (USP/NF & FCC), are unique among contract manufacturing and packaging companies:

  • Stability testing—accelerated and room temperature
  • Compatibility testing—container vs. contents
  • Validations (equipment cleaning, mixing, filling/packaging, test method)
  • Method transfer validations
  • Analytical and wet chemistry testing

Stability is an important principle in the Medical Device and Pharmaceutical industries. Multi-Pack Solutions offers stability testing as a service to its customers. Product samples are pulled periodically and placed in a controlled environmental chamber of temperature and humidity to test whether they remain within the chemical and microbiological specifications. This ensures the product’s effectiveness and makes certain it is not harmful in any way.

Purified Water System

Another unique feature at Multi-Pack Solutions’ Greenville facility is a USP-grade purified water system. The reverse osmosis system with Ozonated loop offers greater disinfection effectiveness against bacteria when compared with chemical disinfectant treatments. Microorganisms cannot build up a biofilm on the interior walls of the piping in the presence of ozone. Ozone provides a continuous defense against biofilm, eliminating microorganisms that could contaminate products.

Equipment & Processes

Figure 2: Multi-Pack Solutions’ Greenville, SC facility

Quality assurance must extend beyond laboratory environments to the equipment on the manufacturing floor.  To address this, Multi-Pack Solutions performs ongoing inspection and validation of its manufacturing and packaging equipment.  A complete validation program assures that major equipment is handled carefully and maintains a high level of performance via execution of installation, operational and performance qualifications.  A change control checklist is completed to assure procedures are completed and in place for new equipment operation.

Quality assurance also means that your contract manufacturer and packager must be compliant with all EPA and FDA requirements for your specific product and must stay abreast of any changes in regulations. A good contract packaging partner in the healthcare industry must also stay informed of any changes with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.  Multi-Pack Solutions’ industry-leading Quality department stays informed about the scientific and technical aspects of drug registration from numerous regulatory authorities in the pharmaceutical industry.

For example, Unique Device Identification (UDI) became effective September 1, 2016 for Class II Medical Devices. As a contract packager for Medical Devices, preparation to meet that requirement included:

  • Research of which medical devices were affected by the change
  • Deadline for compliance
  • Critical communication with customers impacted by the new requirements and discussion about whether they would be seeking an exemption
  • Software to be used so that Multi-Pack Solutions could assure the selected software would work seamlessly with its customers
  • Equipment needed to implement the change
  • Analysis and validation of the equipment and software used to produce products that fell under the change requirement

Another recent change relates to the Serialization and Aggregation requirement for compliance with the Drug Supply Chain Security Act (DSCSA) for pharmaceutical products. Contract packagers must upgrade coding equipment and integrated software to ensure proper tracking and tracing of products from the manufacturer to the end user. This is performed by numbering—in order—the product produced and assigning this number to each unit as sold. Contract packagers must be fully compliant by November 2017.

A quality agreement should be in place between you and your contract packager that outlines your responsibilities and those of your supplier. Information sharing of quality procedures, registrations and product regulations is critical, and transparency is the key to long-term success. When choosing your contract packaging partner, ask to speak with members of the quality team and review the quality manual and current procedure index.

Establishing direct lines of communication up front will allow you to better head off mistakes, be more efficient and realize success more quickly.

 

NEXT WEEK: SUPPLY CHAIN

A true contract packaging partner will understand your market space and will have developed trusted partnerships all along the supply chain. From healthcare to household cleaners, Multi-Pack Solutions’ track record of success covers a broad range of industries.