cGMP (current Good Manufacturing Practice) is a system of regulations enforced by the FDA to ensure pharmaceutical products are consistently produced and controlled according to quality standards.

Key cGMP requirements:

• Quality systems:Documented procedures, training, and oversight
• Facilities & equipment:Appropriate design, maintenance, and calibration
• Process controls:Validated manufacturing processes with in-process testing
• Materials:Qualified suppliers and incoming material testing
• Documentation:Complete batch records and traceability
• Personnel:Trained and qualified staff

Why cGMP matters:

• Required for clinical trial materials (Phase I-III)
• Mandatory for commercial pharmaceutical products
• Ensures product safety, identity, strength, quality, and purity
• Provides assurance to regulatory agencies and patients
• Minimizes risk of contamination, mix-ups, and errors

We offer comprehensive scale-up capabilities from lab-scale through commercial production with equipment designed for flexible, efficient manufacturing.

Scale ranges:

• Lab-scale:100g - 1kg (5L-20L reactors)
• Pilot scale:1kg - 10kg (50L-100L reactors)
• Commercial scale:10kg - 100kg+ (200L-500L reactors)

Equipment capabilities:

• Glass-lined reactors (5L, 20L, 50L, 100L, 200L, 500L)
• Stainless steel reactors for non-corrosive processes
• Temperature control: -20°C to 200°C
• Pressure capabilities: vacuum to 10 bar
• Inert atmosphere (nitrogen, argon)
• Various agitation systems (anchor, pitched blade, etc.)

We systematically scale from lab to pilot to commercial, validating at each stage to ensure reproducible, robust processes.

Yes, ChemContract operates an FDA-registered facility with full cGMP certification. We maintain comprehensive quality systems and are inspection-ready.

Regulatory compliance:

• FDA-registered drug manufacturing establishment
• cGMP compliance per 21 CFR Parts 210 & 211
• ISO 9001:2015 quality management system
• DEA registration for controlled substances
• OSHA compliance and safety programs
• EPA waste management compliance

Inspection readiness:

• Regular internal audits and mock inspections
• Complete documentation and record retention
• Trained inspection response team
• CAPA (Corrective and Preventive Action) system
• Change control and deviation management

We welcome regulatory audits from FDA, EMA, and other health authorities. Our quality systems are designed to meet international GMP standards including ICH, EU GMP, and WHO GMP.

We provide comprehensive GMP documentation suitable for regulatory submissions including INDs, NDAs, and MAAs.

Manufacturing documentation:

• Master Batch Records (MBR):Detailed manufacturing procedures
• Executed Batch Records:Complete record of each manufacturing campaign
• Certificate of Analysis (CoA):Complete analytical results with specifications
• Certificate of Compliance:GMP compliance statement
• Analytical methods:Validated test methods with protocols
• Stability data:ICH-compliant stability study results

Regulatory support documentation:

• Drug Master Files (DMF Type II or Type III)
• CMC sections for IND/NDA submissions
• Process validation reports
• Equipment qualification documents (IQ/OQ/PQ)
• Cleaning validation reports
• Method validation reports per ICH Q2(R1)

All documentation follows ICH guidelines and is maintained under 21 CFR Part 11 compliant electronic systems with complete audit trails.

Scale-up timelines vary based on process complexity, starting scale, and target scale. We work efficiently while ensuring robust, validated processes.

Typical timelines:

• Lab to pilot (1-10kg):2-4 months
• Pilot to commercial (10-100kg):3-6 months
• Direct lab to commercial:4-8 months

Timeline breakdown:

• Technology transfer & review:2-4 weeks (process review, equipment selection)
• Process optimization:4-8 weeks (scale-up trials, parameter refinement)
• Process validation:6-12 weeks (3 PPQ batches with full testing)
• Stability initiation:Concurrent with validation batches

For urgent clinical needs, we can expedite timelines with dedicated resources. We also offer "bridging" campaigns where we produce material at smaller scale while completing full-scale validation.

Yes, our facility is equipped and permitted to handle a wide range of challenging and hazardous chemistries with appropriate engineering controls and safety protocols.

Capabilities include:

• Low temperature:Cryogenic reactions to -20°C (lower with external cooling)
• High temperature:Reactions up to 200°C in pressure vessels
• High pressure:Hydrogenations and supercritical processes
• Pyrophoric reagents:Grignard, organolithium, alkali metals
• Toxic materials:Proper containment and monitoring
• Explosive intermediates:Risk assessment and mitigation
• Controlled substances:DEA-licensed for Schedule I-V

Safety measures:

• Process hazard analysis (PHA) for all reactions
• Reaction calorimetry for exotherm characterization
• Emergency response procedures and equipment
• Continuous process monitoring and alarming
• Proper PPE and engineering controls
• Trained personnel in hazardous material handling

We maintain a fully equipped analytical laboratory for comprehensive in-process and release testing of all manufactured materials.

Analytical capabilities:

• Identity:NMR (1H, 13C), FT-IR, melting point
• Purity & impurities:HPLC, GC, LC-MS for impurity profiling
• Quantitation:HPLC assay, titration, Karl Fischer
• Physical properties:Particle size, bulk density, polymorphism (XRD)
• Residual solvents:GC analysis per ICH Q3C
• Water content:Karl Fischer titration
• Heavy metals:ICP-MS per ICH Q3D

Quality control testing:

• All methods validated per ICH Q2(R1) guidelines
• System suitability testing with each analysis
• Reference standards traceable to USP/EP
• Out-of-specification (OOS) investigation procedures
• Independent quality review before release

We can also coordinate testing with external specialty laboratories for non-routine analyses (e.g., genotoxicity, mutagenicity).

Yes, process development and optimization are core strengths. Our process chemistry team works to improve existing routes or develop new routes for manufacturing.

Process development services:

• Route scouting:Evaluation of alternative synthetic approaches
• Reaction optimization:DoE (Design of Experiments) studies
• Solvent selection:ICH Q3C-compliant solvent systems
• Crystallization development:Control of polymorphism and particle size
• Impurity fate mapping:Understanding impurity formation and purging
• Cost reduction:Raw material evaluation and process efficiency

Quality by Design (QbD) approach:

• Define Quality Target Product Profile (QTPP)
• Identify Critical Quality Attributes (CQAs)
• Determine Critical Process Parameters (CPPs)
• Establish design space through DoE
• Implement control strategy and PAT

Process development typically takes 2-4 months and significantly de-risks scale-up while improving economics and robustness.

Batch sizes and campaign structures are flexible based on your material needs and development stage.

Typical batch sizes:

• Phase I clinical:500g - 5kg (1-2 batches)
• Phase II clinical:5kg - 20kg (2-3 batches)
• Phase III clinical:20kg - 100kg (3-5 batches)
• Commercial:50kg - 100kg+ per batch

Campaign structure:

• Validation campaign:3 consecutive conformance batches (PPQ)
• Clinical supply:Additional batches as needed for stability and clinical use
• Commercial supply:Ongoing campaigns with annual process review

Scheduling:

• Dedicated manufacturing suites to minimize changeover
• Flexible scheduling to accommodate urgent needs
• Typical lead time: 6-10 weeks after order
• Rush manufacturing available (2-4 week turnaround)

We work with you to right-size campaigns based on your clinical timeline, regulatory strategy, and budget.

Technology transfer is managed systematically to ensure successful process implementation and reproducibility at our facility.

Technology transfer process:

• Phase 1 - Documentation review:Batch records, analytical methods, process understanding
• Phase 2 - Technical assessment:Equipment mapping, gap analysis, risk assessment
• Phase 3 - Method transfer:Analytical method qualification in our lab
• Phase 4 - Tech transfer batches:1-3 batches to demonstrate reproducibility
• Phase 5 - Process validation:PPQ batches under GMP

Success criteria:

• Yield within expected range (±10%)
• Quality attributes meet specifications
• Impurity profile comparable to originator
• Process robustness demonstrated

Communication & collaboration:

• Dedicated project manager as single point of contact
• Regular technical calls during transfer
• Site visits welcome for knowledge exchange
• Post-transfer support (typically 6 months)

We maintain comprehensive quality systems designed to ensure product quality and regulatory compliance.

Quality management system components:

• Quality Manual:Overall quality policy and organization
• SOPs:Detailed procedures for all GMP activities
• Training program:Initial and ongoing GMP training with qualification
• Document control:Version control and approval workflows
• Change control:Risk-based evaluation of process changes
• Deviation management:Investigation and CAPA for deviations
• CAPA system:Corrective and preventive action tracking
• Internal audits:Regular self-inspections and mock audits

Quality oversight:

• Independent Quality Unit (QU) with release authority
• Quality review of all batch records before release
• Annual product quality review (APQR)
• Supplier qualification and management
• Equipment qualification and calibration program
• Environmental monitoring program

Yes, we offer comprehensive ICH-compliant stability testing programs to support regulatory submissions and shelf-life determination.

Stability storage conditions:

• Long-term:25°C/60% RH (ICH Zone II)
• Accelerated:40°C/75% RH
• Intermediate:30°C/65% RH
• Refrigerated:5°C ± 3°C
• Frozen:-20°C ± 5°C

Stability testing:

• Appearance and physical attributes
• Assay (potency)
• Degradation products and impurities
• Water content (Karl Fischer)
• Other critical quality attributes

Study design & reporting:

• ICH Q1A(R2) compliant protocols
• Multiple batch stability for commercial material
• Trending analysis and shelf-life prediction
• Stability reports for regulatory submissions
• Out-of-trend (OOT) investigations

All stability chambers are continuously monitored with alarming and backup systems. We provide secure long-term storage of your API with regular stability monitoring.

Pricing varies based on process complexity, scale, and GMP requirements. We provide detailed quotes after technical review.

Pricing structure:

• Process development:Time & materials or fixed price ($50K-200K typical)
• Tech transfer:Fixed price based on complexity ($25K-75K typical)
• Validation campaign:3 PPQ batches ($100K-300K typical)
• Commercial manufacturing:Per-batch or per-kg pricing

Cost drivers:

• Number of synthetic steps
• Reaction complexity and conditions
• Raw material costs
• Purification requirements
• Batch size and campaign size
• Analytical testing scope
• Timeline (rush surcharges apply)

Payment terms:

• New clients:50% deposit, balance before shipment
• Established clients:Net 30-60 with approved credit
• Long-term supply:Quarterly or annual contracts with volume commitments

Volume discounts available for multi-campaign commitments. We work with your budget to structure optimal manufacturing strategies.

Supply chain security and business continuity are critical for pharmaceutical manufacturing. We implement multiple safeguards.

Raw material management:

• Multiple qualified suppliers for critical materials
• Strategic inventory of key starting materials
• Incoming material testing before use
• Supplier audits and quality agreements
• Change notification procedures with suppliers

Manufacturing continuity:

• Redundant critical equipment
• Backup utilities (power, nitrogen, water)
• Preventive maintenance programs
• Disaster recovery and business continuity plans
• Insurance coverage for business interruption

API storage & distribution:

• Secure, climate-controlled storage
• Inventory management and forecasting
• Distribution agreements with major carriers
• Temperature-controlled shipping when needed
• Chain of custody documentation

Starting a cGMP manufacturing project is straightforward. We guide you through each phase from initial assessment to commercial supply.

The process:

• Step 1:Initial inquiry - provide compound structure and quantity needs
• Step 2:Execute NDA (mutual confidentiality)
• Step 3:Technical package review (synthesis, analytics, specifications)
• Step 4:Feasibility assessment (2-4 weeks)
• Step 5:Detailed proposal with scope, timeline, and pricing
• Step 6:Quality agreement and manufacturing contract
• Step 7:Technology transfer and process setup
• Step 8:Manufacturing and release

Information needed:

• Target molecule structure and specifications
• Synthetic route (or request process development)
• Required quantity and timeline
• Intended use (preclinical, Phase I/II/III, commercial)
• Any existing manufacturing history or batch data
• Regulatory strategy (IND, NDA, MAA)

Contact us today:
Phone: +1 (714) 732-8549
Email: [email protected]

Our cGMP manufacturing experts are ready to discuss how we can support your pharmaceutical development and commercialization.