Kawman Pharma, a division of K.P. Manish Group, is a leading API manufacturing company driven by a steadfast commitment to delivering impeccable quality products. Recognizing the significance of quality in the pharmaceutical industry, Kawman Pharma has formulated a robust quality policy that sets the foundation for their operations. This policy not only aims to surpass customer expectations but also ensures compliance with global standards and regulations. With a strong focus on communication, continuous improvement, and collaboration, Kawman Pharma strives to become synonymous with quality and reliability in the industry.

Quality Assurance

Quality Assurance team ensures highest standards of quality throughout the organization.

  • Focus on continuous improvement and proactive measures.
  • Review and approval of quality-related documents.
  • Monitoring and approving technology transfer processes.
  • Validation master plan review and approval.
  • Oversight of equipment qualification and maintenance.
  • Thorough review of process and cleaning validation protocols.
  • Comprehensive review before batch release.
  • Investigations and corrective actions for deviations and out-of-specification results.
  • Conducting internal audits and driving improvement.
  • Proper handling of changes through documented procedures.
  • Investigation of customer complaints and implementation of corrective actions.
  • Prompt actions for product recalls.
  • Commitment to delivering safe, effective, and high-quality products.

Quality Control

  • Well-equipped QC lab ensuring purity, safety, and effectiveness of products.
  • Rigorous analysis process adhering to regulatory requirements and guidelines (Schedule M, USFDA, EU, WHO).
  • Compliance with CGMP and GLP standards for highest quality control.
  • Separate Instrumentation laboratory with state-of-the-art equipments.
  • Chemical and instrumentation analyses based on Pharmacopoeia specifications.
  • Analytical Method validations and verifications following ICH and Pharmacopeia guidelines.
  • Routine stability studies based on ICH guidelines.
  • Regular calibration and preventive maintenance of instruments.
  • Forced degradation studies for robust and reliable testing methods.
  • Microbiology laboratory for TAMC, TYMC, and Pathogen analyses.
  • Environmental analyses for a safe production environment.
  • Meticulous quality control practices for safe, effective, and reliable products.

Microbiological Laboratary

  • State-of-the-art QC & Microbiological Laboratory complying with GLP/GMP regulations. Focus on contamination control and maintaining high-quality standards.
  • Equipped with advanced analytical instruments for various processes. Specialization in method development, validation, stability studies, forced degradation studies, etc.
  • Real-time data storage with audit trail for transparency and accountability. Microbiology lab meets testing requirements for sterile products, including BET and pathogen identification.
  • Commitment to Any Time Audits for continuous audit readiness. Dedicated team for quality assurance and regulatory support.
  • Comprehensive support for working standards, reference standards, and impurity standards. Cutting-edge technology, stringent quality control, and regulatory compliance for reliable results.