quality

Quality

Quality at Nabiqasim is more of a lifestyle rather than a set of regulations.

Quality at Nabiqasim begins with management commitment & ends up with transformation of Customer’s voice into reality of quality built in product(s). The quality at nabiqasim comprises of three pillars: Quality Control, Quality Assurance & Quality Management, which have interrelated operations for customer satisfaction & high degree of confidence. We ensure the quality is adamant and persistent in our products to meet & exceed customer expectations.

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Quality Control

Quality Control at Nabiqasim has put in place the infrastructure, qualified instruments, competent, highly qualified, experienced and trained professionals to ensure consistent quality of its products through Chemical & Microbiological Testing as per compendia and in-house validated methods. The state of the art Laboratory equipped with latest sophisticated instruments to monitor the entire manufacturing process at every step involved from selection of raw materials to transformation of quality finished products.

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Quality Assurance

Quality Assurance at Nabiqasim means totality of arrangement for quality drugs which includes cGMP Compliance Monitoring at Production, Quality Control, Utilities, Material Management, Administration & Regulatory Compliance which has direct & indirect impact on product Quality, Safety, Purity & Efficacy.

Quality Assurance at Nabiqasim is independent & committed to ensure that the entire operations of its manufacturing facility meets the required cGMP standards and products manufactured therein conforms to the internationally accepted standards throughout its shelf life.

Execution of Validation Master Plan through Annual Validation Plan & we at Nabiqasim are successively complying the validation requirement like.

  • Utilities/System Qualification (HVAC, Water, Compressed Air, Pure Steam)
  • Equipment Qualification
  • Analytical Method Validation
  • Process Validation
  • Aseptic Process Validation
  • Cleaning Validation
  • Computer System Validation

Supplier Qualification with coordination of Supply Chain Management is base of quality raw materials & packaging components. QA has emphasis upon Analysis of Data through Annual Product Review (APR), Quality Risk Management (QRM), Handling & Investigation of Compliant, Deviation & Change Control, Self Inspection/Technical Audit & cGMP Training Plan to Worker & Executive Staff. QA has microscopic role at Nabiqasim & everything has to pass through it.

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Quality Management Systems

Quality Management has been established at Nabiqasim to integrate quality assurance (QA)/good manufacturing practices (GMP)/quality control (QC) through trained & IRCA qualified staff. To understand specific requirements on quality management it includes: Organization, Procedures, Processes and Resources through implementation of ISO 9001:2008, as Certified by Bureau Veritas Pakistan (Pvt.) Ltd {UKAS-United Kingdom}. Quality Management also focus on compliance of ISO 14001:2004 & OHSAS 18001:2007 through internal procedures. Internal Quality & HSE Audits, Management Review, Training, Control & Distribution of all documentation through intranet (e-distribution) are secret of compliance.

Quality Management provide solid foundation for systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for “Quality”. The totality of these actions serves to generate confidence in our Quality System at Nabiqasim.

QA, GMP and QC are interrelated aspects of Quality Management at Nabiqasim.