Manufacturing

Quality Control

PreEmptive Meds, Inc. is commited to providing you with the highest quality nutraceutical products.  To this end, Pmeds partners with state-of-the-art manufacturing facilities in USA, which complies with all FDA regulations. To ensure quality and tranparency, each product is subject to the following requirments:

• Batch # printed on every bottle’s label with manufacturing Date & Expiry Date.
• Independent Testing by Nationally Recognized Body for Quality Management for:
• Product is tested for label claims including active ingredient verification and verification of all “No”, “Free from” or “Allergen” claims (i.e. "no fat, no sugar").
• Product is tested for contaminants including heavy metals, aflatoxins, microbiological contaminants, pesticides, etc.
Product goes through a toxicological review for potential toxicity from consumption.
• Certificate of Analysis available for every batch.

Description of the quality control system

Refer to the Quality Manual cited under1.9 and summarize batch release procedures (review of BMR, IPC and QC data, final approval by Authorized person or QA/QC manager.

NHK Laboratories developed and implemented the Quality Management System (QMS) described in this manual to help our organization demonstrate its ability to consistently provide products/services that meet customer and applicable regulatory requirements, and operate with increased effectiveness and efficiency with the overall aim of enhancing customer satisfaction.

Before product is released for distribution, the completed production batch record is thoroughly verified, in-process controls and QC tests data is reviewed by the authorized QC/QA personnel or manager. QC./QA has final authority to accept or reject product release for distribution.

Sample check list blank forms used by quality control before product release

Production

Description of the Production Operation

A master manufacturing record (MMR) is created. The MMR contains detailed information about the formulation of the product, description of ingredients and weight of ingredients and description of all the processes included in the production. A production batch record (PBR) is created for every lot based on the MMR, and the PBR is approved and released by the Quality Control department for production operation. All production operation are carried out as per the specifications mentioned in the PBR and Quality Assurance continuously monitors every step of production, and at every critical step QA reviews the materials in process, and makes a disposition decision before release it to next step.

Handling of starting materials , packaging materials, finished products , quarantine , release and storage Raw materials and packaging components are procured by the company from qualified suppliers. All raw materials and packaging components are procured with predetermined specifications. Once the materials shipment arrives at Pmeds Manufacturing Facility, Shipping and Receiving department receives with required documents such as Certificate of Analysis (COA), Packing Slip, transport details etc.

All materials are quarantined before accepted by the Quality Control department. Sampling of raw materials conducted using a statistically acceptable method and sampled material is reviewed by conducting identity, microbiology, potency and other physical tests against COA. A disposition decision is made based on the rest results, by authorized Quality Control personnel to accept or reject the material shipment. QC accepted materials are released from quarantine and moved to warehouse storage at controlled conditions. Upon conformation of and , and the Purchasing department at Pmeds Manufacturing Facility procures the raw materials specifications

Handling of rejected materials

Rejected raw materials are kept in a designated area and accessible to authorized personnel only. Suppliers of the rejected raw materials notified about the reasons for rejection. Rejected raw materials will be returned to the suppliers upon their request or disposed at Pmeds Manufacturing Facility.