QUALITY MANAGEMENT


Our dedication to quality in everything we do is uncompromising and covers every stage of the development

A Quality par-excellence, delivering shamelessly is our hallmark.

  • Sam Chem Healthcare quality supervision is demonstrated at all phases of product life cycle. Quality evaluation begins with careful documentation. This ensures compliance with good laboratory practices and consequently integrity of the data produced. Quality supervision is continued for production, distribution and conclusion for shelf life of product.
  • Our commitment to quality and adherence to best practices has proven itself time and again. Sam Chem Healthcare couples product innovation with standardized manufacturing processes to deliver exceptional value to customers. To this end the company has been certified by various independent bodies and has memberships with premier industry associations.
  • We at Sam Chem Healthcare  are committed to supply good quality products, excelling laid down standards to delight our customers by continually upgrading our skill, technology, processes and complying to Good Manufacturing Practices and Quality Management Systems.
  • “We strive for Total customer satisfaction through continuous improvements in processes and systems, delivering consistent quality meeting International standards”

Corporate Quality & Compliance


Our Corporate Quality & Compliance (CQC) team regularly updates sites as per the requirement for continual improvement. The team follows standardized global quality system procedures to ensure consistency, effectiveness and efficiency during the manufacture of APIs and formulations at all sites. CQC monitors the effectiveness of quality systems of manufacturing sites and contract manufacturing sites through periodic quality reviews, periodic audits and review of compliance to regulatory inspections. The quality reviews focus on review of batch failures, batch rejections, market complaints, deviation, various corrective and preventive actions planned, etc.

We have world-class & robust quality systems installed to ensure that all the products manufactured are consistently safe and of good quality. To add to it, the presence of well-qualified and trained personnel in the quality department ensures GMP compliance at every step of the process.

POLICY

We strive for total customer satisfaction through continuous improvements in processes and systems, delivering consistent quality meeting International standards.

Continuous endeavors to innovate and improve our Facilities, Products, Processes and Procedures.

It is our conscious effort to make sure that all employees have the appropriate education, training, skills, and experience to carry out their work competently.

CONTROL

With the objective to provide always safe product, Quality Control department works consistently with accurate analytical methods.

The laboratory is well equipped with modern & sophisticated instruments like UPLC, HPLC with auto-sampler, FTIR, TOC & dissolution apparatus for bioequivalence studies. The laboratory conducts Stability Studies as per current ICH guidelines.

ASSURANCE

The Quality Assurance department ensures that quality safety and efficacy are designed and built into our products.

We ensure that all the functions of QC & manufacturing are well controlled by Quality Assurance. All the major stages of manufacturing process is validated to ascertain that every product we manufacture conforms over its shelf life to Internationally accepted standards of quality, purity, efficacy and safety.