Our Quality Assurance Measures

We secure your success through innovation and dedication to our QA measures.

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Discover Our Commitment to Quality

At ChemRite CoPac, we approach every project with an intense focus on product quality from beginning to end. Whether it’s an automotive appearance product or an over-the-counter (OTC) item, each product undergoes the same rigorous quality inspection process. Our comprehensive quality assurance program provides a crucial control mechanism for consistent and sustained quality during each step of production.

Validated Quality and Production Controls

Ensuring true quality and production control requires validated procedures. ChemRite CoPac’s quality procedures are detailed in our Quality Assured Manual, which provides a systematic approach for each job function, lab procedure, cleaning and sanitization standard, batching, production, and maintenance practice. Our quality management team has validated each procedure, and any revisions require a document revision log entry and a five-point sign-off from senior management. Our employees are trained and supervised to adhere to these processes.

Quality Assured Test Methods

ChemRite also has an extensive library of validated test controls known as QATM (Quality Assured Test Methods). Each QATM provides detailed instructions for performing specific analytical tests. Our quality technicians adhere to these methods for all quality testing, ensuring test results meet pre-approved standards.

Create the Best Version of Your Product With Our Manufacturing Services

From formulation to packaging, our team is hyper-focused on the overall customer service and compliance within your project.

  • Batch Assays, Production Inspections, and Final Product Release Protocol

    At ChemRite CoPac, meticulous quality inspection is integral throughout the filling and packaging process. Quality Control (QC) technicians continuously monitor each step, starting with line start-up inspections and including recurring checks as specified by the customer. QC personnel oversee various packaging factors, such as fill weight, cap placement, leakage, and label placement, to ensure that every job is done correctly the first time. Additionally, date coding is applied to all packages and shipping cartons for accurate tracking.

  • Ongoing Audits and Corrective Action Procedures

    ChemRite CoPac collaborates with a wide network of quality vendors and service providers. To uphold our high standards, we have an extensive audit and validation program for all products, equipment, vendors, and service providers. New material vendors are required to provide a current quality control policy or certification demonstrating a quality control system. Service providers must comply with ChemRite’s quality protocols and OSHA safety standards. If any vendor or service provider encounters a quality issue, they must go through a corrective action procedure to resolve it.

  • Archive of Raw Material and Batch Retain Samples

    ChemRite CoPac archives raw materials and batch retain samples in compliance with cGMP requirements. Raw material retains are stored alongside their respective assay sheets. All batch retains are batch coded and stored in a temperature-controlled, password-protected room monitored by our Quality Control director. This ensures traceability and compliance with regulatory standards, maintaining the integrity of both raw materials and finished products.

Partner With Our Dedicated Team for Uncompromising Quality and Safety

Let our team guide you to excellence in quality and safety for every product you manufacture. With our consistency and drive, we constantly achieve superior results for our customers.

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Comprehensive Testing Capabilities

ChemRite’s facilities include two state-of-the-art laboratories equipped with instrumentation to provide a wide range of testing capabilities. Our quality team provides analytical testing expertise to support compliance with FDA Good Manufacturing Practice (cGMP) requirements. Our capabilities include:

  • Gas Chromatography (GC)
  • Fourier Transform Infrared Spectroscopy (FTIR)
  • High-Performance Liquid Chromatography (HPLC)
  • pH Testing
  • Viscosity Testing
  • Density Measurement
  • Specific Gravity Measurement
  • Turbidity Testing
  • Standard Wet Chemistry Analysis

Experience Normalized Excellence With ChemRite CoPac

Let us help you create a product you can be proud of. Reach out to our team with the parameters of your project for a free quote and a tailored solution.

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