Melhores Práticas para o Gerenciamento de Produtos Farmacêuticos Perigosos

Configurar contenção, embalagem e rotulagem para prevenir liberações durante o manuseio e transporte

Implementar contenção de dupla camada: utilizar recipientes primários selados dentro de um sistema secundário com superfícies não porosas, bandejas de derramamento e absorventes capazes de capturar pelo menos 110% do volume do maior recipiente. Esta abordagem minimiza liberações durante o manuseio e transporte de rotina, protegendo o meio ambiente e a saúde do pessoal. O fabricante deve garantir que os fechamentos sejam invioláveis e que os componentes de contenção sejam mantidos e testados em uma base rotineira, sendo parte do programa geral para operações de logística. No entanto, o assunto de contenção permanece uma responsabilidade compartilhada entre fabricantes e geradores.

• Design de contenção

  • Recipientes primários: estanques, quimicamente compatíveis com o conteúdo e construídos em HDPE, vidro ou aço inoxidável, conforme apropriado.
  • Contenção secundária: uma bandeja ou tambor com borda elevada e revestimento não poroso; capacidade ≥ volume do maior recipiente × 1,10; incluir material absorvente que possa capturar todo o conteúdo de uma unidade com vazamento.
  • Incompatibles: segregate packages to prevent cross‑reaction; use separate outer packaging and dedicated pallets when needed.

• Packaging specifications

  • Inner packaging: cushioned, shock‑absorbing inserts; use liners and seals to prevent leakage and evaporation during temperature excursions.
  • Outer packaging: UN‑classified or compatible design for transport; ensure moisture and impact resistance; use sturdy fiberboard or composite boxes with clearly visible handling indicators.
  • Labeling on packaging: place content‑description labels on both primary and outer containers; include net quantity, batch/lot numbers, and temperature requirements when applicable.

• Labeling and markings

  • Use GHS‑compliant labels with English and local language where required; bold, legible typography; include handling instructions and emergency actions for spill scenarios.
  • Display two labels: one on the primary container and one on the outer package; ensure readability through moisture and abrasion‑resistant materials.
  • Temperature controls: clearly mark storage and transport conditions (e.g., refrigerated, controlled room temperature) to prevent degradation or leakage.

• Documentation, training, and records

  • Document all containment and packaging choices in a shipment file: container type, lot numbers, dimensions, materials, and test results; maintain well organized records for audits.
  • Training: provide hands‑on training for personnel involved in handling, packing, labeling, and loading; refresh at least annually or upon process change; ensure certifications are current.
  • Logistics coordination: designate responsible professionals in the chain (shippers, carriers, receiving sites) and issue a clear handoff protocol; track shipments until delivery is confirmed.

• Compliance, exemptions, and continuous improvement

  • Refer to the rule and subpart for shipment requirements; certain shipments may be exempt under specific conditions until new guidance is issued. Keep the publication current and align with issued updates.
  • Position statements: the manufacturer’s stance emphasizes preventive containment as part of the general program; however, operators being trained should apply the same standards in the field.
  • Recordkeeping and document control: store all packaging and labeling decisions in the official publication or document repository; make them accessible to professionals involved in handling and disposal processes.
  • Disposal considerations: establish a defined procedure to dispose of any leaked residues in accordance with general environmental requirements and local health codes; do not dispose of leaking containers as general waste without prior containment and cleanup.
  • Operational note: the negative‑pressure zone in receiving areas can help contain small leaks during inspection and transfer, reducing risk to personnel and surroundings.

In practice, the program should reflect being consistent with the manufacturer’s standards and the broader regulatory framework; use a documented checklist to verify that each shipment meets containment, packaging, and labeling criteria before movement in the logistics chain. An example in the publication uses the name mccoy as a placeholder operator to illustrate the workflow, reinforcing the need for precise documentation and trained professionals to uphold these controls.

Document and code waste correctly: generator status, manifests, and EPA waste codes

Rather than relying on memory, keep generator status current in the management center and attach a manifest that aligns with the listing. Use a signed, issued manifest that is finalized prior to shipment, and assign the corresponding EPA codes to each line item. Wastes are documented to allow protection of staff, the public, and the environment.

1. Verify generator status in the management center; if active, finalize a manifest; if the status changes, sent updated documents and keep the prior version to enable comparison.
2. Link each line to the listing; determine which EPA code applies; when a product fits more than one listing, include the primary code and note alternatives; certain drugs, including over-the-counter formulations, are mapped accordingly; such mapping ensures accuracy and compliance.
3. Record february shipments comprehensively; include date, the signed manifest, and the copies that were sent; store these in a secure center; keep documentation with protection for access controls.
4. Label container contents clearly; ensure solid packaging that protects handlers; track the chain of custody through the facility, with documentation that accompanies each container.
5. Maintain a position of accuracy while changes occur; final and finalized documents reflect the current status; issue updated manifests and provide evidence of sending; such actions reduce negative discrepancies.
6. Ensure data elements are complete: generator ID, destination, and the relevant fields; signed records show changes and the issued date; the notes should indicate where the item entered the program, and which listing applied.
7. Keep a master log of all wastes; include the date sent, the recipient, and the disposition; the official said credits apply when appropriate.

Establish safe storage practices: accumulation limits, segregation, and spill control

Recommendation: cap on-site accumulation of hazardous wastes from pharmaceutical activities at ninety days. This policy requires closed, compatible containers inside secondary containment with a surface that is impermeable to liquids. That setup reduces surface release risk and protects health in busy spaces. Label each container with contents, generation date, and waste code, and keep a running log to support disposal planning and credit under the program.

Segregation: separate streams by hazard class. Keep discarded pharmaceutical wastes away from dietary items and over-the-counter medicines. Where incompatible materials could react, store them in different cabinets with clearly marked, sealed containers. The expectation is that staff follow a subject policy and that items with differing hazard profiles remain isolated. Small-volume containers deserve extra attention to leakage and spill-prevention measures. A proposed segregation model aligns with the policy and may exempt non-hazardous items from co-location in the same area.

Containment and surface protection: install secondary containment beneath all storage units capable of handling the largest container; ensure surfaces are smooth, washable, and resistant to chemical attack. Implement a spill-control kit interval, update absorbents, and verify that a spill release can be contained within minutes. Training should occur on a regular cadence, with february reviews to validate readiness and documentation.

Disposal and transport: plan ship movements of discarded substances to approved facilities under a documented policy. Each shipment includes a waste profile, a bill of lading, and the appropriate credit to compliance records. This subject area must remain within legal constraints and may exempt certain non-hazardous items from specific handling steps. Drinking-water areas and food-preparation zones should be kept separate from storage to minimize cross-contact risk.

Training and continuous improvement: establish a formal training program that spans handling, spill response, labeling, and disposal steps. The february audit cycle should assess adherence, accuracy of waste inventories, and effectiveness of segregation. The organization should track surface contamination, release events, and any discarded materials, updating the policy accordingly.

Coordinate compliant reverse logistics: transport, chain-of-custody, and incident reporting

Implement policy and guide that assigns accountability to a dedicated team and to those themselves who handle returns; shipments of drugs and related materials must move through a verified chain of custody, with entries signed and time-stamped in the log.

Select licensed carriers and set a transport SOP that covers packaging, labeling, and container integrity; ship items only in compliant packaging, with tamper-evident seals; maintain a single electronic manifest sent with the load; use GPS tracking and digital handoffs to prove where each item was at every moment; however, if a dispatch cannot meet timelines, hold items until resolution.

Chain-of-custody must be airtight: each transfer requires a signed acknowledgement; update the register with time, location, and custodian; ensure data flows through the system so auditors can review each step within a defined window.

Incident reporting: define what constitutes an incident (spill, leakage, mislabel, loss, or release); trigger immediate isolation, documentation, and notification to the policy owner; report through the rulemaking channel and update the guide accordingly; conduct a root-cause analysis and implement corrective actions, then re-scan to confirm closure. mccoy position informs the governance layer.

Recordkeeping and categorization: the scope includes drugs and other materials, including dietary items, food, and household items; track items through their journey until returned to an approved facility; classify items as final, reusable packaging, or waste to the extent allowed; use a policy-based register that supports cross-reference of shipping, receiving, and disposal steps; ensure that all communications are in clear words and signed by relevant parties.