How to Design & Develop your own line of products:
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Libby Laboratories can develop products to meet a specific idea or new concept, revolve around specific ingredients, match the characteristics & performance of a product you have selected, or work from a formula you have developed yourself or with another formulator. Note that we are a product development and custom manufacturing lab. Everything we do is custom made for each client. We do not have private label products which are ready to order products available for labeling with your own brand. Hence, we do not have a catalogue or off the shelf samples to submit.
Custom made products allow you to get exactly what you want. However, the minimum orders will be larger than for a private label products and small quantity orders will certainly be more expensive.
If you decide that a custom made product is what you want, the first step in development is to discuss your ideas and needs. The more information and details you can supply, the more focused our development can be. Confidentiality is a priority for Libby Laboratories. Libby Labs offers non-disclosure agreements upon request.
Please note that the following label claims turn the product into an Over-the-Counter drug product which will require quite a bit more development time, assay time, and costs are higher to support an Over-the-Counter claim.
Anti-acne, anti-itching, anti-microbial, anti-dandruff, healing, diaper rash, hair growth, insect repellent (EPA regulated), Skin protectant, chapped lip claims, sunscreen, skin bleaching, and muscle aches/pains. There may be other claims which would also make it a drug product.
Libby Laboratories has a complement of fragrances and essential oils to meet basic needs. As scent is a key component to many products, customers often want to have a custom fragrance developed for use in their product line. If you want your own signature fragrance, Libby Labs can suggest several fragrance houses that have excellent reputations for fragrance development. Any raw material component which you supply must be provided from a commercial source acceptable to us. The commercial source must be able to provide the material with a specification sheet and certification of analysis for the lot number supplied.
Libby Laboratories does not stock or purchase packaging components other than standard bulk gallons, 5 gallon pails, and 55 gallon drums. Libby Labs is more than happy to help you find packaging material sources as well as suggest packaging types that might meet your needs.
If we have enough information about the project, we can start by providing some tentative quotation and ingredient data for your review.
If tentative quotation and ingredient data are in range, Libby Lab’s qualified chemists will prepare an initial sample of your formulation, often at no cost to you. Fees for formula development work reflect your individual project. We will prepare a presentation at your request before doing any work.
We follow a process of sample submittal, evaluation, and feedback with you until we have a formula that meets your aesthetic & performance requirements as well as meeting our stability & preservative efficacy standards.
Most formula samples are tested for physical stability at room temperature, 37°C, and 50°C for 28 days. Concurrently with this stability testing, Libby Labs microbiology department usually runs preservative effectiveness testing to assure that your product is adequately preserved. Other tests may be pertinent for your specified project. If so, these tests will be described to you.
Formulas for Over-the Counter drug products are developed in compliance with FDA drug monographs. Stability testing is required to establish expiration dates. This process is more complex than the one for non-drug products and requires more time. We can provide details relating to your specific product.
At any point in the submittal/evaluation process we can update quotation data to reflect the current formula.
Once you have approved a formula which has acceptable stability & microbiology profiles, and Libby Labs has inspected the packaging components, Libby Labs will provide formal quotation data and ingredient lists.
Producing your Product:
Quotations provided by Libby Labs are usually in quantities that fit our processes & production equipment and give you the best economy of scale. (e.g. This means that if a vessel holds 40 gallons, 40 gallons would give you the best price in that vessel even though we could run a smaller quantity in that vessel – for example 30 gallons ). Libby Labs can often run other quantities as you require.
Purchase orders may be mailed, faxed, or e-mailed to Libby Laboratories. Please indicate on your purchase order the Libby Labs code number & letter of the formula you are ordering, the size(s) you are ordering, the quantity you are ordering, the quotation for each size. We will confirm back to you the estimated deposit needed and quantities of any fragrances or materials you will be supplying for the order. We will need an estimated time of arrival for any components that you are supplying when you place the order.
Processing of non-drug product orders usually requires 4-8 weeks from the date of receipt of your written purchase order, deposit check, and all materials and components supplied by you. New product initial orders will probably take longer depending on complexity and requirements. Once all fragrance, packaging, and raw materials are received at Libby Labs, we will provide an estimated shipping date for the completed order.
Shipping and handling costs will be determined at the time of shipment. All shipments are FOB Berkeley, California. Shipping instructions must be clearly noted on your purchase order. Libby Laboratories ships to one location only. Libby Labs does not handle distribution.
Libby Labs Quality System:
Once your order is placed, Libby Labs orders the raw materials needed for the batch. The raw materials are received at the dock, logged into our database, and put into quarantine. All raw materials, including any materials supplied by you, are logged in, sampled, and tested by our Quality Control laboratory. Once approved, the materials are labeled released for use.
Formal master production and lab documents for manufacturing, packaging, and Quality Control are created for your formula and approved by management. The manufacturing documents usually contain the formula, manufacturing instructions, in-process Q.C. checks, post manufacturing storage instructions, and post-manufacturing Q.C. specifications. The packaging documents usually contain the packaging materials required, the equipment & set-up information needed, any instructions specific to the packaging of your product, and specifics on boxing & palleting of your product. The Quality Control documents list batch information, Q.C. specifications, and test methods.
From these master documents, copies are made and filled out for the specific batch size, weights of raw materials needed, quantities released for filling. All calculations and information are double checked by quality personnel before releasing to production.
Q.C. documents compose a production & quality history as batches are run.
The manufacturing & packaging departments use these calculated documents to make and fill your product. All raw material identities, raw material weights, production steps, packaging components, and packaging specifications are checked by 2 people. After manufacturing & filling, Quality Control & Quality Assurance personnel check all of the documents and the product to assure the quality of your product prior to release.
Once the product is released by our Quality Assurance department, we notify you & coordinate to ship the product per your direction.