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Quality/Compliance

  • Farming and Raw Herb Suppliers Audits
  • Supplier's Questionnaire's
  • Compliance Certifications
  • In-Process Testing in the Country of Origin
  • Independent Laboratory Testing
  • Clinical Trials and Technical Documents

Quality/Compliance

Quality and efficacy of your finished products start with quality of raw ingredients you put in them and it doesn't just show itself in the finished product. Continuous improvement in the quality of the product is the secret for long term success of products in the market.
We, as a supplier understand our customer's concern for the quality of the product we supply, qualification and approval of the supplier. Here we feel pleased and satisfied to ensure and guarantee our customers sincerely the qualification and approval on our behalf.

Quality has very comprehensive meaning and is a big word for majority of the suppliers in the market but for us at Botanic Healthcare it's the core business commitment a promise and surety of your satisfaction. We always strive for unceasing quality improvement that lasts long for our manufacturing capabilities and we also keep on boosting and inspiring our clients to do so who understand and respect our philosophy of selling ingredients that are proven,by independent labs, for their quality identity, purity, potency and strength.

Since the new FDA CGMP regulations for dietary supplement manufacturers came into effect, majority of the manufacturers struggled in this field just because they never had manufactured and exported in the way Botanic Healthcare does and our foremost attention is focused on to maintain commitment to quality and wellbeing of the end users. Main emphasis of FDA cGMP regulation is all around proven quality of ingredients, the manufacturer who were able to prove that the ingredients they used in their supplements had been tested and proved for identity, purity, potency and strength, happily continued their business as usual, however, the ones who failed to prove the quality of their ingredients were served with warning notices.

It's not about just sending the sample to the laboratories for identity or assay test but it is to understand the physical and chemical composition of the ingredients, and then to decide which test methodology would be most appropriate to give us quality and genuine results. In dealing with Botanic Healthcare you can be assured that we have exhaustive experience and technical knowledge of different herbal and universally published pharmacopoeias in dealing with different ingredients.Therefore we know which technical protocols works for different ingredients.

We believe in "Once tested, everywhere accepted". It's not about manipulating the methods to achieve results to put on specification. It is about going for the research for the methods and employing only the best of those which would give true results so that the materials may come under customers' specified limits.

Quality System at Botanic Healthcare follows FDA cGMP guidelines for Supplier approval and qualification.

  • Farming and Raw Herb Suppliers Audits

    We review our raw material suppliers and farming plants we deal with twice a year, using rigorous assessing process. We don't have to go long distance for this as we have very strong base indifferent regions in India where many of our farmers reside. We go and visit the farms and warehouses and audit them to the Western Quality Standards. We explain to them our requirements and that of our customers and suggest them whatever feasible improvement or solutions they can carry out for long term quality improvements. It is this partnership approach that produces the greater quality and reliability on Botanic Healthcare's products, at the same time we ensure that our raw materials remain economical as far as prices are concerned as compared to other manufacturers.

  • Supplier's Questionnaire's

    Where it's not feasible for us to visit our international herb raw material farmers and suppliers, we develop most stringent quality system questionnaires for raw herb suppliers that they have to answer the requisite queries aimed at testing the quality and commitment of the suppliers. This way we recognize their farming and quality system followed by raw herb identification and qualification process.

  • Compliance Certifications

    We only deal with farmers and raw herb suppliers who hold current compliance certification issued by authentic regulatory bodies accepted at international level. We, as part of our in-house quality assurance system, verify the legitimacy and validity of that certification.

  • In-Process Testing in the Country of Origin

    For many of our clients we provide them with process testing results for various ingredients and this way the clients get their custom made standardized extracts.

  • Independent Laboratory Testing

    Before any of our material gets shipped from the origin of the country to any client across the globe, it has to pass through a three-step testing. The first stage of testing is in-house-in-process quality testing done by our production team and then the second stage of testing is done on finished products by our Quality Control Department and then the third stage of control gets taken over by QA at Botanic Healthcare for that particular batch and finalized by the independent International accredited laboratories approved by the client. After all this testing it is guaranteed that the products you receive at your door step will never be rejected by any lab. It's up to our customers to perform the fourth stage of testing as per their in-house quality systems. Many of our clients find themselves satisfied with independent testing laboratory results we provide them with certificate of analysis for each batch. Again it depends on the supplement companies to which country they want to sell their products and what the requirements are in the market. However, we always holdup quality of our supplied products until they get cleared by our customers in their in-house inventory control system.

  • Clinical Trials and Technical Documents

    It's very easy to find one particular ingredient at different prices from numerous suppliers or brokers but our main emphasis is to streamline our manufacturing process. We are committed to provide all the technical documents, stability data and clinical study data (if any done) for each ingredient we supply to our customers with whom we have put down in place confidential agreements.

    The following is the list of Technical Documentation you can expect from us :

     

    • Comprehensive Certificate of Analysis
    • Technical Data Sheets (TDS) along with vital information regarding excipient, residual solvent, part of plant used and country of origin.
    • Comprehensive Material Safety Data Sheets (MSDS)
    • Scientific Data in power point slides or scientific papers to prove the use and efficacy of the ingredient.
    • Nutritional composition and value.
    • Allergen Fact Sheets along with allergen statements.
    • BSE/TSE statements along with supporting documents.
    • GMO free statements.
    • Process flow charts.
    • Method of analysis for ID, potency/strength, and Purity Testing employed by manufacturers.
    • Halal and Kosher certifications for specific ingredients
    • Compliance certification for manufacturing plants.

Our endeavor is aimed at providing all above mentioned documents with supporting evidence for client's approval before we supply any product to them.