History
Production
Pacific Pharma manufacturing facilities are located in China, strictly following GMP (Good Manufacturing Practice) rules and regulations. We conduct regular internal and third-party facility inspections to ensure all products meet and exceed the standards required by buyers.
Internal QA management systems ensure that all facilities follow the official standards.
Our diversified product system enables the scaled operation of resources, not only creating added value for customers but also extending this value to end-users.
We always adhere to two core directions: providing high-quality products at affordable prices; and deeply meeting the personalized needs of buyer customers and their target markets by precisely coordinating market adaptability and product differentiation advantages.
We have established an end-to-end infrastructure network to achieve full visual control over the supply chain. Raw material suppliers, third-party consultants, and other stakeholders undergo rigorous evaluation to ensure compliance with official standards.
Through real-time data analytics, we dynamically monitor supply chain operations to guarantee precision and efficiency; meanwhile, we proactively implement anti-counterfeiting measures to resolutely eliminate product counterfeiting.
Quality
Upholding excellent quality standards serves as the core pillar of our business. From product research and development to manufacturing and terminal sales, the philosophy of quality has been deeply ingrained in every link of the entire process.
Regulatory Share | ICH Q7: 10 Core Points of GMP for Active Pharmaceutical Ingredients (APIs)
ICH Q7 (Guideline for Good Manufacturing Practice for Active Pharmaceutical Ingredients (APIs)) is the globally unified API GMP standard developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Centered on the principles of controllable quality, full traceability, and risk-based approach, it covers the entire API manufacturing process.Below are its ten core elements, refined in line with the original guideline and industry practices, which are fully applicable to API production across various categories including biological APIs and chemically synthesized APIs.
Quality Management System (QMS)：Independent closed-loop system + Continuous improvement
Core Requirements
Establish a systematic Quality Management System (QMS) covering the entire API manufacturing process. Clearly define that the Quality Unit (QU) shall be independent of the production department, and shall undertake core responsibilities including approval of quality standards, batch release, and deviation review, which shall not be delegated to other personnel.
Key Actions
Conduct regular internal self-inspections (audits) and annual product quality reviews. Through deviation management and CAPA (Corrective and Preventive Actions), form a closed-loop process of "identify problems – resolve problems – verify effectiveness" to drive dynamic optimization of the quality system.
Core Objectives
Ensure that quality decisions are free from production interference, and guarantee the quality consistency and compliance of APIs.
Personnel Qualification & Hygiene：Competence Matching + Hygiene Standards
Core Requirements
Maintain a sufficient number of qualified personnel with appropriate education, training, and practical experience matching their job responsibilities. Establish a company-wide GMP training program covering key areas including process operation, quality risk management, and data integrity.
Key Actions
Develop personnel hygiene procedures (e.g., clean room clothing, health monitoring) to prevent contamination caused by personnel. External consultants must possess professional qualifications, and their service scope and qualifications shall be fully documented and on file.
Core Objectives
Control operational risks from the human factor source, and ensure all relevant personnel are competent to perform their duties.
Buildings & Facilities：Appropriate Design + Contamination Control
Core Requirements
Facility layout shall clearly separate functional areas such as production, storage, and QC. Cleanliness grades shall be established according to process requirements, and appropriate pressure differentials shall be maintained to prevent cross-contamination.
Key Actions
Utilities (ventilation, lighting, drainage) shall be validated to meet production needs. Highly sensitive APIs (e.g., penicillins) and highly toxic APIs (e.g., cytotoxic drugs) shall use dedicated production areas or equipment. Production water shall meet intended use requirements (at least WHO drinking water standards; stricter chemical/microbiological standards shall be established if necessary) and be monitored regularly.
Core Objectives
Provide hardware support for API manufacturing, and prevent risks of environmental and cross-contamination.
Process Equipment Management：Compliance Validation + Maintenance & Calibration
Core Requirements
The design and selection of production and testing equipment shall be adapted to process requirements, facilitating cleaning, maintenance, and calibration. A life cycle management system for equipment shall be established, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Key Actions
Develop a preventive maintenance plan, regularly calibrate critical instruments such as pH meters, balances, and chromatographs, and maintain records. Computerized systems shall meet data integrity requirements (e.g., audit trails, access control) and comply with regulatory requirements such as 21 CFR Part 11.
Core Objectives
Ensure that equipment is always in a "qualified state" and guarantee the stability of process operation and the accuracy of testing data.
Materials Management：Full Process Control + Traceability
Core Requirements
Cover all categories of materials used in API production, including starting materials, intermediates, and packaging materials, and implement full-process control over "receipt – waiting for inspection – sampling – testing – release – storage – usage".
Key Actions
Verify supplier qualifications and CoA (Certificate of Analysis) upon material receipt; isolate and label non-conforming materials. Implement temperature and humidity monitoring in the storage area and follow the "First In, First Out (FIFO)" principle. Establish a material traceability system to record material flow and batch usage, ensuring traceability.
Core Objectives
Prevent non-conforming materials from entering production and ensure the quality of the API is controllable at its source.
Production & In-Process Control：Parameter Control + Complete Batch Records
Core Requirements
Production operations shall follow the approved Master Production Record (MPR). Critical process parameters (such as reaction temperature, time, and pH) shall be defined with control ranges through validation, and production data shall be recorded in real time.
Key Actions
Define in-house standards and shelf life for intermediates, and implement in-process sampling and testing. Strictly control production time limits to prevent material degradation. Batch Production Records (BPR) shall fully document all operations, equipment usage, and deviations to ensure the traceability of the production history of each batch, and shall be reviewed by the Quality department.
Core Objectives
Ensure that production processes are "implemented in accordance with standards" and guarantee batch-to-batch consistency of APIs.
Laboratory Control & Data Integrity：Method Validation + Data Reliability
Core Requirements
The QC laboratory shall establish a systematic control system to ensure the accuracy and reliability of test results, supporting the release and stability evaluation of APIs.
Key Actions
Analytical methods shall be validated in accordance with the requirements of ICH Q2 (R2), covering attributes such as specificity, accuracy, and precision. OOS (Out of Specification) and OOT (Out of Trend) results shall be handled strictly, and root cause investigations shall be conducted. A stability monitoring program for APIs shall be established, and the shelf life or retest period shall be determined based on data. Sufficient reserve samples shall be retained to meet the requirements for traceability and retesting.
Core Objectives
To provide "scientific evidence" for the quality evaluation of APIs and ensure that release decisions are based on reliable data.
Validation & Qualification：Scientific Compliance + Coverage of Key Links
Core Requirements
Adopt a risk-based approach and conduct validation for critical processes, cleaning procedures, analytical methods, etc., to ensure they are in a controlled state.
Key Actions
Process validation shall cover three stages: design, qualification, and ongoing validation. Cleaning validation shall establish acceptance criteria for residues based on "worst-case scenarios" to demonstrate the effectiveness of equipment cleaning. Validation documentation shall be complete and standardized, including validation protocols, data records, reports, and conclusions, with regular reviews of the validation status.
Core Objectives
Use scientific validation to prove that "processes are controllable and results are reproducible," meeting the core regulatory requirements for API manufacturing.
Documentation & Record Keeping：Closed-loop control and risk assessment
Core Requirements
Establish a systematic change and deviation management process. All changes and deviations that affect API quality shall be controlled to prevent quality risks caused by uncontrolled changes.
Key Actions
Changes shall be reviewed and approved according to their impact level (e.g., major changes require validation and regulatory filing). Evaluate their impact on product quality and process stability.
Deviations shall be recorded timely, with root cause investigation conducted. CAPA shall be developed and its effectiveness verified.
Records of changes and deviations shall be incorporated into batch records to ensure traceability.
Core Objectives
Prevent quality fluctuations caused by changes and deviations, and maintain the stability of the quality system.
Deviation, Change Control & CAPA：Full-process protection and traceability
Core Requirements
Cover the entire process of API from production completion to customer delivery, ensure that quality is not affected during packaging, storage and transportation, and achieve full traceability throughout the process.
Key Actions
Packaging materials shall meet the API stability requirements. Labels shall clearly indicate key information such as name, batch number, expiry date and storage conditions; the issuance and use of labels shall be controlled.Storage areas shall meet temperature and humidity requirements, and the expiry dates of materials shall be inspected regularly.A traceability system shall be established for the distribution process to record transportation conditions (e.g., temperature control), so as to ensure stable API quality within the shelf life.
Core Objectives
Guarantee API quality throughout its life cycle and prevent quality issues caused by improper packaging, storage or transportation.
Key Supplementary Requirements
The ten core components of ICH Q7 are interconnected, forming a full-lifecycle quality management model featuring a quality system as the framework, personnel as the foundation, facilities and equipment as the guarantee, processes as the core, and data as the support.It is aligned with guidelines such as ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System), providing a unified GMP baseline for global API manufacturing.ICH Q7 serves as the core basis for API manufacturers to achieve regulatory compliance and access international markets.
What Makes Us Difference
Brands
Our products have gained widespread trust and recognition from pharmaceutical enterprises and medical professionals and consumers. This advantage endows buyer clients with strong market competitiveness, assisting them in achieving strategic goals such as market penetration, expansion of market share, enhancement of brand awareness, and expansion of product portfolios.