Markek Certifications

Pharmaceuticals & Healthcare

Markek Certifications > Industries > Pharmaceuticals & Healthcare

Why Compliance is Essential in Pharmaceuticals & Healthcare?

The pharmaceutical and healthcare industry operates under strict global regulations to ensure that medicines, medical devices, and healthcare products are safe, effective, and legally approved. Compliance is crucial for patient safety, quality assurance, and international trade success.

  • Patient Safety & Public Health – Prevents contaminated, counterfeit, or substandard drugs from reaching consumers.
  • Regulatory Approval & Market Access – Ensures compliance with WHO, FDA, EMA, SFDA, and global health authorities.
  • Quality Control & Risk Management – Guarantees consistency in drug formulation and safety standards.
  • Good Manufacturing Practices (GMP) & Good Distribution Practices (GDP) – Mandates quality assurance in manufacturing and supply chains.
  • Traceability & Pharmacovigilance – Enables tracking medicines from production to distribution and ensures monitoring of adverse effects.
Markek’s Role: At Markek International Certifications, we help pharmaceutical manufacturers, medical device companies, and healthcare brands comply with global regulatory standards, ensuring safe and legal trade worldwide.
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Testing – Ensuring Pharmaceutical Safety, Efficacy & Quality Compliance

Why Testing is Important?

Pharmaceutical and healthcare testing is vital for ensuring product integrity, regulatory compliance, and patient safety.

Key Testing Parameters for Pharmaceuticals & Healthcare Products:

Test Type

Test Parameters

Purpose

Active Pharmaceutical Ingredient (API) Testing

Purity, Potency, Stability

Ensures correct composition & drug effectiveness

Microbiological Testing

Sterility, Bacterial Endotoxins, Microbial Limits

Prevents contamination in injectable & oral medicines

Chemical & Residue Analysis

Heavy Metals, Pesticide Residues, Solvent Residues

Detects toxic substances & residual solvents

Dissolution & Bioavailability Testing

Drug Release Rate, Absorption

Ensures proper absorption & effectiveness in the body

Stability Testing

Shelf Life, Environmental Stress Testing

Confirms product effectiveness under different conditions

Medical Device Testing

Biocompatibility, Mechanical Strength

Ensures medical devices are safe for human use

Packaging & Labeling Compliance

Dosage Instructions, Batch Numbers, Expiry Date

Prevents mislabeling & ensures product traceability

 

Global Standards & Regulations for Testing:

  • WHO GMP (Good Manufacturing Practices) – Establishes global pharmaceutical quality standards.
  • FDA (Food & Drug Administration, USA) – Ensures pharmaceutical safety & efficacy.
  • EMA (European Medicines Agency) – Governs medicines in the European market.
  • SFDA (Saudi Food & Drug Authority) – Regulates pharmaceutical & medical device compliance in Saudi Arabia.
  • ISO 13485 (Medical Devices) – International standard for medical device manufacturing.
  • ISO 17025 (Pharmaceutical Testing Laboratories) – Governs laboratory testing accuracy & quality.

Markek’s Role: We connect pharmaceutical & healthcare manufacturers with accredited testing labs to ensure global compliance with international health standards.

Inspection – Ensuring Compliance in Manufacturing & Distribution

 Why Inspection is Important?

Pharmaceutical & healthcare inspections ensure quality, safety, and regulatory compliance throughout the manufacturing and supply chain process.

Key Benefits of Pharmaceutical & Healthcare Inspections:

  • Prevents Counterfeit & Substandard Medicines – Ensures only genuine, high-quality medicines enter the market.
  • Guarantees GMP Compliance & Manufacturing Quality – Verifies adherence to Good Manufacturing Practices (GMP).
  • Reduces Recalls & Export Rejections – Prevents non-compliant medicines from facing legal bans.

Key Inspection Parameters for Pharmaceuticals & Healthcare:

GMP (Good Manufacturing Practices) & Facility Inspections

  • Production Line & Cleanroom Inspection – Ensures contamination-free drug manufacturing.
  • Raw Material & Active Ingredient Quality Checks – Verifies API purity & consistency.

Medical Device & Equipment Inspections

  • Sterility & Biocompatibility Testing – Prevents contamination in medical devices.
  • Material Quality & Mechanical Strength Inspections – Ensures durability & safe use.

Supply Chain & Distribution Inspections

  • GDP (Good Distribution Practices) Compliance – Ensures safe transportation & storage of medicines.
  • Cold Chain Verification – Monitors temperature-sensitive pharmaceutical handling.

Acceptable Quality Level (AQL) Inspection

Objective: Determines the acceptable defect threshold for each batch before shipment.
  • Establishes AQL standards to balance cost and quality.
  • Reduces the risk of major and minor defects in bulk production.
  • Ensures the batch meets international trade and compliance standards.

Measurement & Fit Inspection

Objective: Verifies that clothing and textile products meet size, fit, and proportion standards.
  • Ensures dimensions match the approved specifications.
  • Prevents issues related to shrinkage, fabric stretch, or incorrect sizing.
  • Reduces customer complaints and product returns.

Piece-by-Piece Inspection

Objective: Examines each individual product to ensure it is free from defects before shipment
  • Identifies stains, holes, misaligned seams, loose buttons, or fabric damage.
  • Guarantees high-quality finishing in embroidery, printing, and stitching
  • Prevents defective items from reaching customers.

Pre-Shipment Inspection (PSI)

Objective: Ensures that semi-finished or finished goods meet all quality and compliance requirements before packing and shipping.
  • Final verification of product specifications, packaging, and labeling.
  • Detects defects before shipping, preventing costly product recalls
  • Ensures compliance with country-specific import/export regulations.

During Production Inspection (DPI)

Objective: Conducted midway through production (20-30% completion) to detect and address defects early.
  • Prevents quality issues before mass production is completed.
  • Identifies problems with fabric, stitching, printing, and assembly.
  • Helps manufacturers correct issues before large-scale defects occur.
 Key Areas Checked in DPI:
  • Fabric Quality – Inspects for holes, stains, or inconsistencies.
  • Stitching & Construction – Checks seam strength and durability.
  • Measurements & Sizing – Ensures garments meet size specifications.
  • Color & Design Consistency – Matches approved color and design samples.

Container Loading Inspection (LS)

Objective: Verifies safe loading and packaging of textile products to prevent damage during transit.
  • Ensures correct product quantities and types are loaded.
  • Checks packaging security, sealing, and labeling accuracy.
  • Confirms proper weight distribution in shipping containers.
  • Inspects container cleanliness and safety compliance.

Verify product quality at every stage with professional textile inspections.

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Certification – Achieving Regulatory Approval for Market Entry

Once pharmaceuticals, medical devices, and healthcare products pass testing and inspection, they require certification to ensure regulatory approval and smooth market entry.
Key Certifications for Pharmaceuticals & Healthcare:
  • GMP Certification – Ensures safe, high-quality drug manufacturing processes.
  • ISO 13485 Certification – International standard for medical device compliance.
  • WHO Prequalification – Certifies global pharmaceutical compliance for public health programs.
  • SFDA Certification (Saudi Arabia) – Mandatory for pharmaceutical exports to KSA.
  • EMA Certification (Europe) – Required for medicines entering the EU market.
  • FDA Approval (USA) – Ensures legal compliance for pharmaceuticals in the U.S..
  • CE Marking (Medical Devices – Europe) – Allows medical device exports to Europe.

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