Quality Assurance
Overview of Quality System
Quality Assurance (QA) plays a critical role in ensuring that products are consistently produced and controlled according to quality standards.
Quality System at ALS
QHSE (ISO)
ISO-9001
ISO-14001
OHSAS-18001
Quality Policy
Legal Compliance
Legal Compliance/Risk assessment
Quality Objective
Environmental Aspect and Impact
HSE Policy, HIRA
cGMP (ICH Guidelines)
Product
System
ROS, Process Flow, BMP
SOP, Format, Annexure
SMF
BMR, BLR,ECR
Audit Trail & Back up Data
Validation Master Plan
Specification of RM/PM/IP/INT/FP
Document Control & Issuance
Qualification (DQ, IQ, OQ, PQ)
Customer VQ. Audit, Declaration
Change Control, Deviation
Preventive Maintenance
Process & Analytical Validation
OSS, Market Complain
Calibration of Equipment
Stability/Holding time, APQR/Quality Summary
Job Responsibility. Training
Validation of Water System, Equipment holding
RM,PM Vendor Approval, VQ
Internal/External Audit, CAPA
Document Storage
- Compliance with Regulations: QA ensures that all processes adhere to current Good Manufacturing Practices (cGMP) and regulatory standards ICH Q7.
- Document Control: QA manages all the documentation required for product development, manufacturing, testing, and distribution, including Standard Operating Procedures (SOPs), batch records, and validation reports.
- Product Testing & Release: QA oversees the testing of raw materials, in-process materials, and finished products to ensure they meet specified quality standards before being released to the market.
- Validation & Qualification: QA is responsible for validating processes, equipment, and methods to ensure they perform consistently and produce quality results. This includes cleaning validation, process validation, and equipment qualification.
- Deviation Management & CAPA: QA monitors deviations from standard procedures, conducts investigations, and implements corrective and preventive actions (CAPA) to prevent recurrence.
- Internal Audits & Inspections: QA conducts internal audits to ensure compliance with internal and external standards. They also prepare for and manage external regulatory & Customer audits.
- Training: QA ensures that all personnel involved in production, testing, and quality control are properly trained in cGMP and other relevant requirements.
- Continuous Improvement: QA promotes continuous improvement by analyzing quality trends, identifying areas for improvement, and implementing process enhancements.
- Conducting Quality Reviews (APQR).
- Change control and handling of market complaints.
- Preparing specification for RM, intermediates, in-process analysis and finished products and their test methods, making CTD (technical document) etc… as per sop’s and customer requirement.
- Prepare “Site Master File” , Qualification & Validation (facility, equipment, analytical methods and process validation) and update it as and when necessary.
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