Quality Assurance
Quality Beyond Compliance
At SK pharma Ltd (Salah Kakar Pharmaceutical Company), quality is not simply a department or a regulatory requirement—it is the foundation of our organization and the driving force behind every pharmaceutical product we manufacture.
We recognize that every medicine produced by our company directly impacts patient health. For this reason, quality is integrated into every stage of our operations, from supplier qualification and raw material selection to manufacturing, packaging, laboratory testing, product release, storage, and distribution.
Our Quality Assurance (QA) Department oversees a comprehensive Pharmaceutical Quality Management System (PQMS) designed to ensure that every product consistently meets predefined standards for safety, efficacy, identity, purity, strength, and quality.
Through continuous improvement, scientific risk management, and adherence to GMP rules we are committed to providing medicines that healthcare professionals and patients can trust with confidence.
Our Quality Policy
Quality is embedded in our culture and reflected in every activity throughout the organization.
SK pharma is committed to:
- Manufacturing safe, effective, and high-quality pharmaceutical products.
- Complying with all applicable regulatory requirements.
- Implementing internationally accepted pharmaceutical quality systems.
- Promoting a culture of continuous improvement.
- Preventing quality defects rather than correcting them after occurrence.
- Ensuring complete product traceability.
- Investing in employee training and competency.
- Delivering products that consistently meet customer expectations.
- Every employee is responsible for maintaining quality and protecting patient safety.
Pharmaceutical Quality Management System (PQMS)
Our Pharmaceutical Quality Management System provides a structured framework for planning, controlling, monitoring, and continually improving pharmaceutical quality.
The PQMS integrates all quality-related activities, ensuring that manufacturing processes remain controlled, documented, and scientifically justified.
Key elements include:
Good Manufacturing Practices (GMP)
SK pharma operates in accordance with the principles of GMP which provide the foundation for consistent pharmaceutical quality.
Our GMP program focuses on:
Quality Assurance Responsibilities
The Quality Assurance Department independently oversees all activities that may affect product quality.
Major responsibilities include:
QA functions independently from production to maintain objectivity and ensure that quality decisions are based on scientific evidence and regulatory requirements.
Documentation System
SK pharma maintains a controlled documentation system that ensures all manufacturing and quality activities are accurately recorded, reviewed, approved, and archived.
Controlled documents include:
- Standard Operating Procedures (SOPs)
- Master Manufacturing Records
- Batch Manufacturing Records
- Batch Packaging Records
- Specifications
- Test Methods
- Validation Documents
- Equipment Logbooks
- Calibration Records
- Cleaning Records
- Training Records
- Audit Reports
- Investigation Reports
- Quality Manuals
- Document control ensures that only current, approved versions are used throughout the organization.
Validation and Qualification
Validation provides documented evidence that processes consistently produce products meeting predetermined quality requirements.
Our validation program includes:
Internal Audits
Internal audits provide independent evaluation of quality system effectiveness.
Audit programs cover:
- Production
- Warehousing
- Engineering
- Laboratories
- Documentation
- Training
- Utilities
- Cleaning
- Calibration
- Supplier Management
Audit findings drive continual improvement across the organization.
Supplier Qualification
SK pharma evaluates suppliers based on:
- Quality Systems
- Regulatory Compliance
- Manufacturing Capability
- Product Quality
- Technical Support
- Audit Performance
- Reliability
Approved suppliers undergo periodic performance review to maintain qualification status.
Quality Control Laboratory
Our Quality Control Laboratory supports pharmaceutical manufacturing through scientific testing and analytical evaluation.
Laboratory functions include:
Raw Material Testing
Verification of identity, purity, assay, and compliance with specifications
Packaging Material Testing
Evaluation of packaging materials before approval for production.
In-Process Testing
Monitoring manufacturing processes to ensure product consistency.
Finished Product Testing
Comprehensive analysis before batch release.
Stability Testing
Monitoring product quality throughout shelf life.
Environmental Monitoring
Routine monitoring of manufacturing environments to maintain conditions.
Stability Studies
Product stability studies provide scientific evidence supporting shelf life and storage conditions.
Our stability program includes:
- Accelerated Stability Studies
- Long-Term Stability Studies
- Ongoing Stability Monitoring
- Parameters evaluated include:
- Appearance
- Assay
- Dissolution
- pH (where applicable)
- Moisture
- Microbiological Quality
- Related Substances
Stability studies are conducted according to approved protocols and regulatory expectations.
Product Release
Sk pharma product is not released for sale until it has successfully completed all required quality evaluations.
Batch release includes verification of:
- Manufacturing documentation
- Packaging documentation
- Laboratory testing
- Deviations
- CAPA status
- Specifications compliance
Final release authorization is granted only after Quality Assurance confirms that all requirements have been met.
Complaint Handling
Customer feedback provides valuable opportunities for improvement.
Our complaint handling system ensures:
- Prompt investigation
- Scientific evaluation
- Root cause determination
- Corrective actions
- Customer communication
- Trend analysis
Patient safety remains the highest priority during every investigation.
Product Recall System
Although our goal is to prevent quality issues, SK pharma maintains documented recall procedures to ensure rapid and effective response should a recall ever become necessary.
The recall system includes:
- Risk assessment
- Regulatory notification
- Customer communication
- Product traceability
- Product retrieval
- Investigation
- CAPA implementation
Training and Competency
Quality depends on knowledgeable and competent personnel.
Employees receive ongoing training in:
- Good Manufacturing Practices (GMP)
- Good Documentation Practices (GDP)
- Standard Operating Procedures (SOPs)
- Data Integrity
- Hygiene
- Safety
- Equipment Operation
- Quality Awareness
Training effectiveness is periodically evaluated to ensure continued competency.
Continuous Improvement
Quality is a journey of continuous advancement.
SK pharma regularly reviews quality performance indicators, audit findings, customer feedback, deviation trends, CAPA effectiveness, and regulatory developments to identify opportunities for improvement.
By embracing innovation and operational excellence, we continuously strengthen our quality systems and manufacturing capabilities.
Our Commitment to Patients
Every medicine manufactured by SK pharma ultimately reaches a patient who relies on its quality, safety, and effectiveness.
This responsibility inspires us to maintain the highest standards throughout every aspect of pharmaceutical manufacturing.
Our commitment extends beyond regulatory compliance—it reflects our dedication to protecting patient health and improving healthcare outcomes.
Building Trust Through Quality
Trust cannot be inspected into a product; it must be built into every process.
At SK pharma, quality is achieved through scientific knowledge, disciplined execution, experienced professionals, modern technology, and an organizational culture that places patient safety above all else.
As we continue to expand our manufacturing capabilities and product portfolio, our commitment to quality remains unwavering.
We believe that by maintaining robust quality systems today, we contribute to healthier communities tomorrow.
