Manufacturing & quality

Manufacturing topics

13 topics · 10 with coverage

• GMP & CGMP

  Current good manufacturing practice: 21 CFR 210/211, EU GMP and its annexes, PIC/S, and how the agencies read them.

  No coverage yet — we track it, and will report it when it moves.

• CMC

  Chemistry, manufacturing and controls: specifications, comparability, stability and the CMC content of a filing.

  3 stories on this site

  • FDA Drafts New Guidance on Drug Container Closures
  • FDA Publishes Its Playbook for Fast-Track CMC Readiness
  • MHRA Approves the World's First Low-Carbon Asthma Inhaler

• Process Validation

  Process design, qualification and continued verification; scale-up and transfer between sites.

  1 story on this site

  • FDA Publishes Its Playbook for Fast-Track CMC Readiness

• Aseptic & Sterile Manufacturing

  Fill-finish, aseptic processing, Annex 1, lyophilisation and the sterile injectable supply base.

  2 stories on this site

  • FDA Flags Novo Nordisk's Indiana Plant as Highest Risk
  • FDA Eases Compounding Rules for Newborn IV Nutrition

• Sterilization

  Ethylene oxide, radiation, steam and emerging modalities: capacity, validation and the rules around each.

  No coverage yet — we track it, and will report it when it moves.

• CDMOs & Contract Manufacturing

  Outsourced manufacturing and testing: the CDMO base, quality agreements, and who answers when a site fails.

  1 story on this site

  • FDA Flags Novo Nordisk's Indiana Plant as Highest Risk

• Pharmacy Compounding

  503A pharmacies and 503B outsourcing facilities: enforcement, shortage lists, essentially-a-copy and beyond-use dating.

  2 stories on this site

  • FDA Hits Empower Pharmacy With Fifth Warning Letter
  • FDA Eases Compounding Rules for Newborn IV Nutrition

• Supply Chain & Shortages

  Drug and device shortages, import alerts, onshoring, serialization and traceability, and disruptions to supply.

  4 stories on this site

  • Sanofi Recalls Insulin Pens, Sarclisa Over Cold Chain
  • FDA Eases Compounding Rules for Newborn IV Nutrition
  • Boston Scientific Cyberattack Halts Device Shipments
  • FDA's GDUFA IV Plan Would Raise Foreign Drug Fees

• Packaging & Container Closure

  Container closure systems, extractables and leachables, labeling errors, cold chain and packaging-driven recalls.

  3 stories on this site

  • Sanofi Recalls Insulin Pens, Sarclisa Over Cold Chain
  • Teva Canada Recalls Acetaminophen Over Resin Risk
  • FDA Drafts New Guidance on Drug Container Closures

• Facilities & Equipment

  Plants and sites, cleanrooms, water and HVAC systems, equipment and registration of establishments.

  4 stories on this site

  • FDA's GDUFA IV Plan Would Raise Foreign Drug Fees
  • FDA Would Let Distributed Manufacturers Register Once
  • FDA Eases Compounding Rules for Newborn IV Nutrition
  • FDA Flags Novo Nordisk's Indiana Plant as Highest Risk

• Advanced Manufacturing

  Continuous, distributed and point-of-care manufacturing, additive manufacturing, PAT and the frameworks that admit them.

  1 story on this site

  • FDA Would Let Distributed Manufacturers Register Once

• Biologics Manufacturing

  Upstream and downstream bioprocessing, vector and cell manufacturing, potency assays and biomanufacturing capacity.

  No coverage yet — we track it, and will report it when it moves.

• Design & Production Controls

  Design controls and design changes, production and process controls, UDI and device master records.

  2 stories on this site

  • France Pulls Getinge Vascular Grafts Over Yarn Defect
  • FDA Posts First Two Warning Letters Under New QMSR

Quality topics

13 topics · 10 with coverage

• Quality Management Systems

  QMSR, ISO 13485, ICH Q10 and the pharmaceutical quality system: what the regulations require and how they are enforced.

  1 story on this site

  • FDA Posts First Two Warning Letters Under New QMSR

• CAPA, Deviations & Complaints

  Corrective and preventive action, deviations, nonconformances, out-of-specification results and complaint handling.

  1 story on this site

  • France Pulls Getinge Vascular Grafts Over Yarn Defect

• Inspections

  FDA and other agency inspections: Form 483s, OAI/VAI classifications, inspection programmes and how they are changing.

  3 stories on this site

  • EMA Extends PV Inspections to Cover Subcontractors
  • FDA Flags Novo Nordisk's Indiana Plant as Highest Risk
  • FDA Launches Council to Overhaul Its Inspections

• Warning Letters & Enforcement

  Warning and untitled letters, consent decrees, injunctions, seizures, import alerts and debarments.

  3 stories on this site

  • FDA Hits Empower Pharmacy With Fifth Warning Letter
  • FDA Posts First Two Warning Letters Under New QMSR
  • FDA Flags Novo Nordisk's Indiana Plant as Highest Risk

• Recalls & Field Actions

  Recalls, market withdrawals, field safety notices and corrections, suspensions and their root causes.

  4 stories on this site

  • Sanofi Recalls Insulin Pens, Sarclisa Over Cold Chain
  • France Pulls Getinge Vascular Grafts Over Yarn Defect
  • Teva Canada Recalls Acetaminophen Over Resin Risk
  • MHRA Lifts Suspension on Belzer Organ-Preservation Fluid

• Data Integrity

  ALCOA+, audit trails, Part 11, computer software assurance and the electronic records behind a batch.

  1 story on this site

  • Boston Scientific Cyberattack Halts Device Shipments

• Supplier Quality

  Supplier qualification and audits, purchasing controls, raw-material and component quality, and subcontractor oversight.

  2 stories on this site

  • Teva Canada Recalls Acetaminophen Over Resin Risk
  • EMA Extends PV Inspections to Cover Subcontractors

• Validation & Qualification

  Equipment and facility qualification, cleaning and method validation, revalidation and the documentation each demands.

  No coverage yet — we track it, and will report it when it moves.

• Sterility & Microbiology

  Sterility assurance, environmental monitoring, bioburden and endotoxin, contamination control strategies and microbial findings.

  3 stories on this site

  • FDA Flags Novo Nordisk's Indiana Plant as Highest Risk
  • MHRA Lifts Suspension on Belzer Organ-Preservation Fluid
  • Teva Canada Recalls Acetaminophen Over Resin Risk

• Quality Risk Management

  ICH Q9, ISO 14971, FMEA and the risk-based approaches the agencies now expect to see documented.

  2 stories on this site

  • FDA Posts First Two Warning Letters Under New QMSR
  • FDA Drafts New Guidance on Drug Container Closures

• Audits, Certification & MDSAP

  Internal and external audits, MDSAP, notified-body certification, ISO 9001 and mutual-recognition arrangements.

  No coverage yet — we track it, and will report it when it moves.

• Change Control

  Change control, variations, prior-approval supplements, CBE-30, annual reports and ICH Q12 lifecycle management.

  2 stories on this site

  • MHRA Approves the World's First Low-Carbon Asthma Inhaler
  • FDA Posts First Two Warning Letters Under New QMSR

• Documentation & Training

  Batch records, SOPs, document control and the training records inspectors ask for first.

  No coverage yet — we track it, and will report it when it moves.

Who reads it

The professions who act on a manufacturing or quality story, and what we have published for each.

15 professions · 13 with coverage

• Quality Assurance leaders

  Heads of QA and quality directors who own the quality system and answer for it in an inspection.

  9 stories on this site

  • Sanofi Recalls Insulin Pens, Sarclisa Over Cold Chain
  • France Pulls Getinge Vascular Grafts Over Yarn Defect
  • Teva Canada Recalls Acetaminophen Over Resin Risk
  • EMA Extends PV Inspections to Cover Subcontractors
  • FDA Eases Compounding Rules for Newborn IV Nutrition
  • FDA Flags Novo Nordisk's Indiana Plant as Highest Risk
  • FDA Posts First Two Warning Letters Under New QMSR
  • MHRA Lifts Suspension on Belzer Organ-Preservation Fluid
  • and 1 more, in the archive

• Quality Control professionals

  Laboratory and release testing, specifications, OOS investigations and stability.

  2 stories on this site

  • Sanofi Recalls Insulin Pens, Sarclisa Over Cold Chain
  • Teva Canada Recalls Acetaminophen Over Resin Risk

• Manufacturing leaders

  Site heads, plant managers and production leaders responsible for making product to the record.

  16 stories on this site

  • France Pulls Getinge Vascular Grafts Over Yarn Defect
  • FDA Flags Novo Nordisk's Indiana Plant as Highest Risk
  • FDA Would Let Distributed Manufacturers Register Once
  • Sanofi Recalls Insulin Pens, Sarclisa Over Cold Chain
  • FDA Hits Empower Pharmacy With Fifth Warning Letter
  • Teva Canada Recalls Acetaminophen Over Resin Risk
  • EMA Extends PV Inspections to Cover Subcontractors
  • FDA Eases Compounding Rules for Newborn IV Nutrition
  • and 8 more, in the archive

• CMC professionals

  The people who write, defend and change the CMC sections of a filing.

  3 stories on this site

  • FDA Drafts New Guidance on Drug Container Closures
  • FDA Publishes Its Playbook for Fast-Track CMC Readiness
  • MHRA Approves the World's First Low-Carbon Asthma Inhaler

• Validation professionals

  Process, cleaning, method and computer-system validation, and qualification.

  No coverage yet — we track it, and will report it when it moves.

• Manufacturing & Process Engineers

  Process development, scale-up, equipment and technology transfer.

  No coverage yet — we track it, and will report it when it moves.

• Supplier Quality professionals

  Supplier qualification, audits, quality agreements and incoming-material quality.

  2 stories on this site

  • Teva Canada Recalls Acetaminophen Over Resin Risk
  • EMA Extends PV Inspections to Cover Subcontractors

• Regulatory Affairs professionals

  Regulatory strategy, submissions and the agency relationship on manufacturing and quality matters.

  12 stories on this site

  • France Pulls Getinge Vascular Grafts Over Yarn Defect
  • FDA Hits Empower Pharmacy With Fifth Warning Letter
  • EMA Extends PV Inspections to Cover Subcontractors
  • FDA Eases Compounding Rules for Newborn IV Nutrition
  • FDA's GDUFA IV Plan Would Raise Foreign Drug Fees
  • FDA Drafts New Guidance on Drug Container Closures
  • FDA Posts First Two Warning Letters Under New QMSR
  • MHRA Lifts Suspension on Belzer Organ-Preservation Fluid
  • and 4 more, in the archive

• Compliance professionals

  Inspection readiness, enforcement response, remediation and compliance programmes.

  6 stories on this site

  • FDA Hits Empower Pharmacy With Fifth Warning Letter
  • EMA Extends PV Inspections to Cover Subcontractors
  • FDA Posts First Two Warning Letters Under New QMSR
  • FDA Launches Council to Overhaul Its Inspections
  • FDA Would Let Distributed Manufacturers Register Once
  • FDA Flags Novo Nordisk's Indiana Plant as Highest Risk

• Operations leaders

  COOs and heads of operations who carry the cost, capacity and continuity consequences.

  3 stories on this site

  • FDA Eases Compounding Rules for Newborn IV Nutrition
  • Boston Scientific Cyberattack Halts Device Shipments
  • FDA's GDUFA IV Plan Would Raise Foreign Drug Fees

• Supply Chain professionals

  Sourcing, logistics, serialization, shortage management and distribution controls.

  4 stories on this site

  • Sanofi Recalls Insulin Pens, Sarclisa Over Cold Chain
  • Boston Scientific Cyberattack Halts Device Shipments
  • FDA Eases Compounding Rules for Newborn IV Nutrition
  • FDA's GDUFA IV Plan Would Raise Foreign Drug Fees

• R&D & Product Development professionals

  Product and process development teams whose choices become the manufacturing record.

  3 stories on this site

  • FDA Drafts New Guidance on Drug Container Closures
  • FDA Publishes Its Playbook for Fast-Track CMC Readiness
  • FDA Posts First Two Warning Letters Under New QMSR

• Sterility & Microbiology professionals

  Sterility assurance, microbiology laboratories, environmental monitoring and contamination control.

  3 stories on this site

  • FDA Flags Novo Nordisk's Indiana Plant as Highest Risk
  • Teva Canada Recalls Acetaminophen Over Resin Risk
  • MHRA Lifts Suspension on Belzer Organ-Preservation Fluid

• Data Integrity professionals

  Data governance, computerized systems, audit trails and Part 11.

  1 story on this site

  • Boston Scientific Cyberattack Halts Device Shipments

• Life-science executives

  CEOs, boards and general managers reading for business risk, cost and exposure.

  4 stories on this site

  • FDA Hits Empower Pharmacy With Fifth Warning Letter
  • Boston Scientific Cyberattack Halts Device Shipments
  • FDA's GDUFA IV Plan Would Raise Foreign Drug Fees
  • FDA Launches Council to Overhaul Its Inspections

The briefs

Six streams of the record, each a filter over the topics above — what each would carry, from the stories the desk has tagged.

6 briefs · 6 with coverage

• GMP & Manufacturing Brief

  Good manufacturing practice, sites and supply: what changed on the plant floor and in the rules that govern it.

  10 stories on this site

  • Sanofi Recalls Insulin Pens, Sarclisa Over Cold Chain
  • FDA Hits Empower Pharmacy With Fifth Warning Letter
  • Teva Canada Recalls Acetaminophen Over Resin Risk
  • FDA Eases Compounding Rules for Newborn IV Nutrition
  • Boston Scientific Cyberattack Halts Device Shipments
  • FDA's GDUFA IV Plan Would Raise Foreign Drug Fees
  • FDA Flags Novo Nordisk's Indiana Plant as Highest Risk
  • FDA Drafts New Guidance on Drug Container Closures
  • and 2 more, in the archive

• Quality Systems Brief

  QMS, CAPA, data integrity, supplier quality and change control: the quality system as the agencies inspect it.

  6 stories on this site

  • France Pulls Getinge Vascular Grafts Over Yarn Defect
  • Teva Canada Recalls Acetaminophen Over Resin Risk
  • EMA Extends PV Inspections to Cover Subcontractors
  • Boston Scientific Cyberattack Halts Device Shipments
  • FDA Posts First Two Warning Letters Under New QMSR
  • MHRA Approves the World's First Low-Carbon Asthma Inhaler

• CMC Brief

  Chemistry, manufacturing and controls: filings, comparability, post-approval changes and the CMC guidance that moves them.

  5 stories on this site

  • Sanofi Recalls Insulin Pens, Sarclisa Over Cold Chain
  • Teva Canada Recalls Acetaminophen Over Resin Risk
  • FDA Drafts New Guidance on Drug Container Closures
  • FDA Publishes Its Playbook for Fast-Track CMC Readiness
  • MHRA Approves the World's First Low-Carbon Asthma Inhaler

• FDA Inspections Brief

  Inspections, 483s, OAI classifications, warning letters and recalls — FDA enforcement as it lands.

  4 stories on this site

  • FDA Hits Empower Pharmacy With Fifth Warning Letter
  • FDA Flags Novo Nordisk's Indiana Plant as Highest Risk
  • FDA Posts First Two Warning Letters Under New QMSR
  • FDA Launches Council to Overhaul Its Inspections

• Medical Device Quality Brief

  QMSR, ISO 13485, design controls, device recalls and field actions, for device quality and regulatory teams.

  4 stories on this site

  • France Pulls Getinge Vascular Grafts Over Yarn Defect
  • Boston Scientific Cyberattack Halts Device Shipments
  • FDA Posts First Two Warning Letters Under New QMSR
  • MHRA Lifts Suspension on Belzer Organ-Preservation Fluid

• Sterility & Microbiology Brief

  Sterility assurance, aseptic processing, sterilization and contamination findings.

  2 stories on this site

  • FDA Flags Novo Nordisk's Indiana Plant as Highest Risk
  • MHRA Lifts Suspension on Belzer Organ-Preservation Fluid