PROJECT INITIATION (Product Development Initiation)
Issuance of PDR – A Product Development Request (PDR) is given to the Head of Laboratory R&D Department. All PDR’s should be accompanied by benchmark/ target/products when possible.
Project Assignment – Upon receipt of the PDR Request, the Head of Laboratory assigns project to the Chemist/formulator for execution.
DEVELOPMENT PROJECT EXECUTION
Patent Check and Review – TThe Chemist/Formulator reviews the project for each project PDR’s for any patents.
Review of Ingredients, Benchmarks, and Actives – At this stage the Chemist/Formulator review ingredients to assign active ingredient. All benchmark products are tested, sampled and retained for design verification.
Drafting of Formulations – The Chemist/Formulator will devise laboratory process procedures. Ingredients are evaluated, tested, and documented.
Formulation Execution – The formulation is executed, batched, sampled, tested, and documented. Formulation is executed infinite number of times until desired outcomes are achieved.
Ingredient Deck Listing – After completion of the Formulation, the Chemist/Formulator prepares the Ingredient INCI deck, MSDS, and product Dossier for client.
Stability Review – Once the formulation is executed the product is subject to stability testing and expiry date determination. This requires three (3) months stability under controlled conditions and humidity. The product is checked periodically for changes and instability. Formulator/Chemist addresses causes of instability.
Established Specification – Once the formulation is executed, the finished product is again tested and subjected to stability. The Chemist/Formulator will design and establish the specification of the product. The formulated product is also sampled and tested for compatibility to components and establishment of fill weights and volumes.
FORMULATION DESIGN REVIEW
Sampling (a) – The formulated products are sampled and submitted for approval to clients and focus group(s). Approval forms accompany all product submissions.
Review, Evaluation and Approvals (b) – Client and focus group review samples. Comments on the formulation are noted on the corresponding approval forms and sent back to the Chemist/Formulator for possible revisions. Once a formulation is approved, the forms and ingredient INCI deck list are signed and documented for final client approval.
Revisions (c) – If formulation is not approved, the revision phase begins. The Chemist/Formulator will reformulate the product addressing noted comments and concerns. The product is again sampled and submitted for final review — following sequence (a) to (b) until approved.
Outside Testing (Third Party Testing) – All new product development should undergo a third party testing, i.e., Preservative Efficacy Testing (PET), Human Repeat Insult Patch Test (HRIPT), Sunscreen (SPF, Critical Wavelength –Optional).
Formulation Approval – Once the product formulation design is approved the product goes to the next step which is Manufacturing and Process Validation.
APPROVAL and MANUFACTURING
Pilot Batching – Prior to mass production, the formulated product is scaled up from a Laboratory batch to a Pilot bath through the supervision of the Formulator/Chemist. All process parameters are documented.
Manufacturing Procedures Development – Upon successful completion of the pilot batch, the Chemist/Formulator works with a Manufacturing Supervisor to design a final manufacturing procedure.
Validation – The formulation is validated three (3) times — batched three (3) consecutive times — under the Chemist/Formulator and Manufacturing Supervisor. All process parameters are verified to be consistent for all batches to be validated.
Mass Production – Upon validation of the process the product is ready for mass production.