Registration Number：MOHW-DM- 012872

Timing Pharmaceutical CO.,LTD.PABP Branch

• Trial Production and Validation:
  Products must pass inspection and validation testing (e.g., analytical method and process validation) and obtain regulatory approval before commercialization. Any mass-production changes trigger change control, potentially requiring re-validation and new regulatory approvals. Validation must strictly meet all criteria: accuracy and precision for analytical methods; uniformity and reproducibility for process validation; and efficacy and consistency for cleaning validation.

• Equipment/Instrument Verification:
  Production equipment and analytical instruments must pass critical verification, including Installation, Operational, and Performance Qualification (IQ/OQ/PQ). Instruments undergo periodic calibration for accuracy, with outsourced calibration managed by certified laboratories.

• Support system verification:
  Manufacturing utilities (HVAC, compressed air) undergo initial hardware and periodic performance qualifications for stability. Additionally, the purified water system requires three-phase qualification and continuous monitoring—testing parameters like microbiology and Total Organic Carbon (TOC)—to ensure water quality.

 Raw materials: The foundation for ensuring the safety and efficacy of traditional Chinese medicine

a. Authenticity and Identification Testing

Through morphological identification and microscopic structural observation

Foreign Matter Inspection

b. Safety Testing
Heavy Metal Residues
Pesticide Residues
Aflatoxins
Sulfur Dioxide

c. Physicochemical and Purity Analysis
Moisture Content and Loss on Drying
Total Ash and Acid-Insoluble Ash
Extractives Determination

d.Quantification of Active and Marker Compounds

(1)  Determination of marker components: using High-Performance Liquid Chromatography (HPLC).

(2) Drying: Tests for moisture content.

(3) Tea Bag Filling and Sorting: The key to ensuring precise product dosage, packaging integrity, and the absence of foreign object contamination.

(4) Semi-finished product awaiting inspection: Sampling and testing execution. Perform description, loss on drying, total ash, acid-insoluble ash, water and alcohol-soluble extract content, heavy metals, identification, and weight variation.

(5) Sub-packaging: Fill volume check. The purpose is to prevent cross-contamination, ensure dosage accuracy, and maintain packaging integrity and correct labeling.

(6) Finished product awaiting inspection: Perform microbiological testing. The purpose is for comprehensive review and final confirmation, ensuring that finished product safety, compliance, appearance, and packaging fully meet regulatory and customer standards.

• In-Process Control & Product Release:

  Raw materials undergo rigorous inspection (e.g., TLC, pesticide residue, specific assays) for identity and specification compliance. During production, In-Process Controls (IPC) are established, with Quality Assurance (QA) enforcing checks—such as weight, filling, and packaging—at critical steps. Upon completing manufacturing and finished product testing, the Quality Management unit and Pharmacist review all batch records to confirm full compliance before authorizing product release.

• Quality Control Testing:

  Product testing is conducted in accordance with officially published pharmacopeias, covering areas such as specific components and identification tests. Products must pass, and the results must be reviewed and approved by the laboratory manager to serve as the definitive basis for product release.

• Quality Management & Compliance:

  The company maintains independent QA and QC units to oversee quality system maintenance and laboratory testing operations. A Pharmacist to manage product quality supervision in full compliance with GMP regulations.

• Product Quality Review (PQR):

  An annual product quality review is conducted for products on the market to track production and testing trends across all batches. This process analyzes variations in product quality (such as assay results and processing conditions). Additionally, stability testing (assay, microbiology, pH, etc.) is performed to monitor changes during storage, ensuring the safety of the product throughout its shelf life.

• Deviation Management System & Customer Complaint Management:

  To maintain and manage the quality management system, the company has established deviation and customer complaint channels. Feedback regarding product abnormalities post-sale is received through customer complaint channels and analyzed via the deviation management system using tools such as fishbone and the 5-Whys. Corrective actions and preventive actions (CAPA) are then formulated to eliminate the root causes and prevent recurrence, thereby mitigating the risk of quality deviations.