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.
In- Process sampling procedures and controls
At each critical control steps of manufacturing process of product, a statistically valid sampling plan is followed for sample collection and analysis. Quality Assurance reviews and approves test results of in-process product before releasing the materials to following processes.
Final product sampling procedures and controls
Final product samples are collected using a statistical sampling plan. These samples are used for laboratory testing and analysis including potency tests against label claims, microbiological purity, and stability studies. The product disposition is determined by laboratory test results of the sample product. Quality Control department evaluates the laboratory test results of each product and makes a decision to release or not to release for distribution. The samples are stored for 3 years after the product is released from Pmeds Manufacturing Facility.
In- Process sampling procedures and controls
At each critical control steps of manufacturing process of product, a statistically valid sampling plan is followed for sample collection and analysis. Quality Assurance reviews and approves test results of in-process product before releasing the materials to following processes.
Final product sampling procedures and controls
Final product samples are collected using a statistical sampling plan. These samples are used for laboratory testing and analysis including potency tests against label claims, microbiological purity, and stability studies. The product disposition is determined by laboratory test results of the sample product. Quality Control department evaluates the laboratory test results of each product and makes a decision to release or not to release for distribution. The samples are stored for 3 years after the product is released from Pmeds Manufacturing Facility.
Reprocessing
Quality Control department analyze production batch records and the data and laboratory test results of every product, and makes independent decisions on the disposition of products. If there are any deviation found, QC will initiate a corrective action including reprocessing of products to meet specifications.
Description of general policy for process validation
Both analytical and manufacturing processes are validated and documented for establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics. Process validation protocol specifies a sufficient number of replicate process runs to demonstrate reproducibility and provide an accurate measure of variability among successive runs. The test conditions for these runs should encompass upper and lower processing limits and circumstances, including those within standard operating procedures, which pose the greatest chance of process or product failure compared to ideal conditions; such conditions have become widely known as "worst case" conditions.
Packaging
State of the art packaging facility at Pmeds Manufacturing Facility, is equipped with packaging equipment and packaging lines for packaging solid dosage forms such as tablets, two-piece capsules, soft gels and powder blends in bottles and jars.
Labeling
As a private label contract manufacturer of dietary supplements, established Label Control procedures are in place at Pmeds Manufacturing Facility. Label Control unit is an integral part of Quality Control Department, and controls label receiving, quarantine, verification of label for accuracy, release labels for application on packaged containers. Reconciliation of labels and documentation procedures are in place every time a particular label is utilized.
Description of manufacturing areas
Our contract manufacturing partner, Pmeds Manufacturing Facility Laboratories’ facilities in Santa Fe Springs, California has been certified with “A” ratings under the NPA (formerly NNFA) Good Manufacturing Practices (NPA GMP) program since 2001, the NSF GMP Registration since 2004 and is ISO 9001:2000 registered as part of the NSF GMP 9000 program since 2006. The NPA GMP and NSF GMP programs require an independent audit of our facilities, procedures, training, sanitation and personnel.
NPA and NSF GMP requirements are regulatory requirements that provide guidelines for necessary processes, procedures and documentation to assure the product produced has the identity, strength, composition, quality and purity it is represented to possess. Our new state-of-the-art packaging and laboratory facility is also registered with US Food & Drug Administration as a drug establishment, licensed to process ethical and over-the-counter pharmaceutical products. The ingredients in PreCrea collectively promote weight loss by reducing craving for sweets and desserts (Gymnemasylvestre) and by blocking the break down to complex starch to simple sugars (Salaciareticulata). Twice daily PreCrea along with a low calorie diet and moderate exercise promotes weight loss of 12-15 lbs in 6-8 months
Laboratories
The company is equipped with a State of the Art Quality Control Laboratory for testing raw materials, in-process product and finished product. The Laboratory is has modern scientific equipment such as FTIR, HPLC, GC, UV spectrophotometer, Atomic Absorption Spectrophotometer etc.
Water system
Pmeds Manufacturing Facility is equipped with in-house Water Purification System with a production capacity of 10000 gallons of USP grade water per day. The USP grade water is used as component in the manufacturing processes of products. The water is also used for final rinsing of manufacturing equipment, utensils, floors and walls after cleaning.
Cleaning and sanitation
The company has a Cleaning and Sanitation program in place for Buildings and surrounding parking lots, premises, warehouse, manufacturing areas, manufacturing and packaging floors , walls, manufacturing and packaging equipment and utensils.
Production
The manufacturing and packaging facilities are equipped with modern production equipment designed and suitable for manufacturing processes.