Our Quality Advantage

From our world-class manufacturing facilities and R&D labs to our award-winning customer service teams, quality is KIK Custom Manufacturing’s (KCM) competitive advantage. When you award KCM with your contract business, we ensure products calibrated to your quality specifications every time.

Our plants are FDA-registered and strictly follow the industry’s Current Good Manufacturing Practices (cGMPs). KCM regularly invests capital in each of our plants to ensure continuous improvement and required maintenance of buildings and equipment.

People are a critical part of the quality equation. KCM invests resources in recruiting and retaining only the best personnel in each of our plants. All employees are trained and strictly observe KCM’s safety and quality standard operating procedures (SOPs). Customer specifications and standards are strictly upheld.

Quality and Compliance

KCM has been successful in meeting and exceeding the highest standards of Quality and Compliance required by its customers, the Food and Drug Administration (FDA), and Health Canada.

Quality Resources

KCM has both Operational and Quality leadership with extensive experience in manufacturing regulated products and each site has a Quality Assurance Director on site.

Quality Systems

KCM utilizes a Quality Systems approach to ensure its compliance with regulations and customer requirements. Elements of KCM’s Quality Systems include:

  • Corporate Quality Standards – these Corporate Policies are approved by the executive team at KCM, including the President. They define the standard expectations that all KCM sites must meet with respect to quality and compliance.
  • SOP’s – a complete set of Standard Operating Procedures are in place at each site, using the KCM Quality Standards as its basis, but written specifically to match the technologies and product types at each facility.
  • Lot Control – all materials that are used in specific quantities are received, tested, released, and dispensed according to specific lot numbers. This allows for full control of materials, and traceability if a quality investigation is needed. We understand the status of our raw materials, components, work-in-process, and finished products at all times.
  • Quality Control – Each of KCM’s production sites contain analytical chemistry laboratories which provide site-specific raw material, packaging component, bulk product, and finished product testing as required by our customers’ specifications. Microbiological laboratories exist at our Cortland and Los Angeles sites, and are currently being added to our Chicago facility, to provide a high level of material control and ensure appropriate environmental monitoring of our facilities.
  • Method Development, Validation, and Transfer – KCM has a Method Development, Validation and Transfer organization which can both develop new or transfer existing analytical methods, based on customer needs, and ensure that those methods are validated according to regulatory expectations.
  • Stability – KCM writes Stability protocols and conducts Stability testing for its customers. In the early stages of a project, these same capabilities are used to provide Material Compatibility data during the early formula and package development phases.
  • Validation – KCM has a Validation Department that provides Equipment Qualification, Computer System Validation, Process Validation and Cleaning Validation support for all sites.
  • Change Control – Change Control boards at each location consider product, process, and equipment changes for the impact of such changes to the validated state of the customer’s product. The Quality Assurance department leads the Change Control efforts at each site.
  • Corrective and Preventative Action (CAPA) Program and Trend Analysis – one of the most important elements of a strong Quality System is a robust CAPA program, where actions to solve and prevent recurrence of problems are developed and documented, and developing trends can be analyzed and rectified before they become larger issues that can affect Supply Assurance. KCM systematically tracks and trends its CAPA’s, and this trend analysis is shared with its Executive Management at quarterly “Quality Summits” attended by Production and Quality Management from each production site. The effectiveness of prior, closed CAPA’s are evaluated and monitored at these Summits.
  • Quality Agreements – clear communication and transparency are key to KCM and its relationship with its customers. To help ensure clear communication and eliminate confusion in roles and responsibilities, KCM routinely develops Quality Agreements with its customers. These agreements outline quality system expectations and responsibilities between KCM and our customer, which streamlines communications and ensures that all compliance expectations are met.
  • Site Master Files – for products manufactured for shipment outside the US, KCM’s Regulatory Department maintains and can provide its customers with Site Master Files for each KCM location. This allows our customers to successfully file KCM as the manufacturer of record in its international filings.
  • Supplier Qualification – in cases where KCM purchases materials, suppliers of these materials are evaluated and qualified using KCM’s Supplier Qualification program. This program ensures that all suppliers meet the quality standards of KCM and our customers, ensuring continuous reliability of supply.

Quality Policy

KIK Custom Manufacturing (KCM) is committed to consistently meeting the expectations of our customers and the government agencies that regulate our products and facilities.

We achieve this goal by:

  • Building quality, safety and productivity into everything that we do
  • Implementing cGMP requirements and the necessary SOPs to support all requirements
  • Protecting products from contamination and/or mix-up
  • Implementing effective training programs and procedures that focus on continuous improvement and risk management
  • Holding our employees accountable for excellence
  • Holding our suppliers accountable for excellence, and ensuring compliance through auditing and tracking systems
  • Instituting Continuous improvement feedback derived from internal audits, external audits, CAPAs and process control data
  • Exercising relentless focus on product and process control improvements.