Quality Control Program

Many people speak of quality today.  At ChemRite CoPac, Inc. it is the foundation of everything we do.  In a word, we are “uncompromising” about the quality of the products we produce from start to finish.  We believe that our customers have a right to expect this of us.  As you review our Quality Control Program below, please note the intensity we place on quality at every level of the production process.

Maintaining Product Consistency (Standards and Assays)
It is vital that a product not vary from batch to batch.  We take great pains to assure finished product quality.  Starting with a bench sample of a new product, our trained chemists look for any possible production issues or areas of improvement before production begins.  Once definitive standards have been set, we rigidly maintain those standards for each formula.  Only approved and validated mixing instructions are used during the blending process.  Assays are established for all products and strictly adhered to, assuring these standards are met.  Retain samples, mix sheets and assay records are kept for future reference.

Raw Material Quality (QARM)
A chemical product is the direct result of the compounds which constitute it.  Therefore, each raw material we receive must be assayed and approved before it is used during production.  All product ingredients are quarantined, and used only after they have been “Green” tagged, or passed quality inspection.  Raw material retains are stored along with the products assay sheet.  All compounds are batch coded for future reference.

Packaging Component Inspection (QAPM)
Even the best product available won’t draw a consumer’s eye without an attractive package.  To ensure flawless finished goods, all incoming packaging goods receive inspection.  Each component is checked against standards set specifically for it.  Only approved items leave our quarantine system.  Records of each inspection are kept as a component history.  Lot codes are assigned to each shipment received.  All components are consumed in harmony with FIFO (First In, First Out) procedure.

Packaging Procedures (QAFG)
Meticulous quality inspection continues as each product is filled and packaged.  Quality Assurance personnel monitor every step of the operation - from line start up inspections to customer specified recurring line run checks.  Q.A. personnel oversee packaging factors such as fill weight, cap placement, leakage, label placement, and much more.  Intensive inspection and record keeping assure the job will be done right the first time.  Date coding is affixed to all packages and shipping cartons.

Internal Quality Control (Audits and Validation)
We maintain an extensive audit and validation program of all processes and equipment.  We are capable of process validation, cleaning validation, test method validation, and full gauge R&R (reliability & reproducibility).  In addition to regular customer and FDA audits, we regularly conduct a 328 point self-audit which helps us identify and correct potential production issues before they occur.  Each avenue of audit and validation has been set in place to make sure we fit our customer’s exact needs.