QA
Quality System
Based on the ICH Guideline Q7, SK’s quality system covers the entire manufacturing process from raw material purchasing, warehousing, production, quality control, to delivery of products. GMP compliance is assured to supply high quality pharmaceutical intermediate and API.Since 1998 SK’s manufacturing facility and quality system has been audited more than 20 times from major pharmaceutical companies. Our proven reliability of providing high quality pharmaceutical intermediate and API has allowed us continual supply of our quality product to major pharmaceutical companies. Included among them are top 10 global pharmaceutical companies.
SK continues to improve its quality system and facilities to meet customer’s increasing expectation and requirement for pharmaceutical intermediates and commercial API manufacturing.
Quality Policy
Our policy is to make regulatory compliant material for customers to meet their need. This will allow us to be successful and grow our business. We manufacture products to meet quality requirements, regulatory requirements and delivery timeline for our customers.SK implemented ICH guidelines for research, development, scale-up, pilot and commercial production, testing and release of product as well as other operations. To fulfill our commitment, Compliance with cGMP guideline throughout manufacturing activities, we train personnel with expertise in problem resolution.
Through the quality system management, we continue to provide good quality product with reasonable cost in a timely fashion.
Quality System & Validation System
SK's quality system is composed of 6 subsystems.
- Quality System
- Laboratory System
- Production System
- Material System
- Facility & Equipment System
- Packaging & Labeling System
To verify compliance with SK’s quality principles and to improve our quality system, scheduled regular training and internal audits are performed.
Stringent quality control is enforced to prevent cross contamination from production to release of the product. In the event of a quality issue, we provide prompt attention to investigate for root cause, establish a corrective and preventive action plan in the interests of the customer.
The following is a brief explanation of SK's quality system:
- Training Program
- Job Description & Responsibility
- Job Training Requirement, Scheduled & Repetitive Training by Personal Annual Plan
- Training Record with Evaluation
- Audit Program
- Regular Internal Audit : Once/Year According to Annual Audit Plan
- Supplier Audit for Critical Raw Material and Contract Manufacture Control
- Customer Audit : by Major Pharma Companies, Approved Supplier for API
- Documentation Control System
- Issued, Reviewed, Approved, Distributed, Archived, and Destructed by QA
- Traceable Numbering System & Documentation
- Retention Period Control
- Standard Operating Procedures (SOP) System
- SOP & Annual Review Program
- Change Control System
- Change Control Request for Any Change With Possible Impact on Product Quality
- Change Control Committee for Approval, Reject, Investigation of the Proposed Change
- Non-Conforming Material Control System
- Out-Of-Specification(OOS); Investigation, Corrective and Preventive Actions
- Deviation : Investigation and CAPA
- MRB (Material Review Board) Program : Reprocessing, Rework, Return, Scrap
- Determination of Material Disposition for Non-Confirming Material
- Separate Rework & Reprocess Program
- CAPA (Corrective and Preventive actions)
- Area of Concern From Non-Conformance, Complaint, Audit, Etc.
- Investigation, Corrective and Preventive Action and Effectiveness Evaluation
- Complaint Program
- Investigation, Corrective and Preventive Action
- Response to Customer
- Recall Program
- Vendor Qualification
- Supplier Control for Raw Material as 4 Staged Status & Supplier History
- Sample Qualification by QC Test & Use Test
- Qualification Based on Rating of Supplier Questionnaire, On-Site and Postal-Audit, Quality Agreement
- Material Control System
- Receiving & Inventory Control
- Status and Storage Control
- Release Approval by Quality Unit
- Shipping Control
- Pest Control
- Production & In-Process Control System
- Technical Transfer From R&D to Commercial Site
- Production by Master Batch Record
- Campaign Review
- Annual Product Quality Review
- Equipment Cleaning Program
- Cleaning Procedure & Records
- Maximum Allowable Carryover Control
- Calibration and Preventive Maintenance Program
- Laboratory Control System
- Equipment : Qualification, Calibration and Maintenance
- Sampling
- Retention Sample Control
- Reference Standard and Reagent Control
- ID and Specification for Material, Label and Packing Material
- Investigation Program for OOS & Deviation
- Documentation for Approved Specification & Analytical Test Method
- Testing & Result Report: Notebook, QC Result Report, CoA
- Stability Test Based on ICH Q1
- Analytical Method Validation Based on ICH Q2
- Micro Test for Purified Water and Environmental Monitoring
The Validation System is as Follows:
- Equipment Qualification
- Quality Risk Assessment
- URS, FS&DS, DQ, IQ, OQ and PQ
- Computerized System Validation
- Analytical Method Validation
- Method Development, Qualification and Validation
- Preparation of Routine Test Method with System Suitability Criteria
- Cleaning Validation
- Product Grouping for Worst Case Selection, Equipment Grouping
- ARL(Acceptable Residue Limit) for Swab/Rinse Limit
- 3 Successful Campaign and Annual Evaluation for Effectiveness
- Preparation of Cleaning Procedure for Each Equipment
- Process Validation
- Risk Assessment : Critical & Key Process Parameter
- Production of 3 Consecutive Validation Batches
- Preparation of Master Batch Record for Commercial Production
Regulatory & Customer Audit
Since year 1998, SK has been audited more than 20 times mainly by global major pharmaceutical companies and approved as suitable supplier for pharmaceutical intermediate to commercial API.FDA and EMEA inspections are expected in the 1st half and the 2nd half of 2011 respectively.
