Materials Management in Pharmaceuticals

Materials Management

• The primary goal of pharmaceutical manufacturing operations is to produce finished products from raw and packaging materials.
• Product quality is dependent on the quality of the inputs (materials) and materials management.
• Materials management encompasses the entire process, from vendor selection to finished product delivery.

Introduction

• All incoming materials must be quarantined upon receipt until released for use or distribution.
• Containers of raw materials and packaging materials must be properly labeled to indicate lot number, quantity, and status. (e.g., quarantined, approved, rejected)
• All materials and products must be stored under the manufacturer's or user's specified conditions to prevent contamination.
• Bagged or boxed materials must be stored off the floor.
• Materials must be stored in an orderly manner to enable batch segregation, and stock rotation (FIFO/FEFO).
• Written procedures are required for all materials handling activities (e.g., receipts, identification, storage, handling, sampling, testing, and approvals/rejections).

Purchasing

• Pharmaceutical materials must be purchased according to approved specifications.
• Specifications must cover the grade, quality, packaging, and containers.
• Material quality must include physical, chemical, and microbiological compliance with pharmacopoeial specifications or in-house specifications.
• Vendor selection should prioritize quality considerations.
• Other commercial considerations (price, delivery period) should be considered alongside quality.
• Materials should only be sourced from approved suppliers/manufacturers.
• RM/PM should only be purchased by trained buyers with sufficient technical knowledge. Materials managers may perform this function, or industrial pharmacists with materials management training.

Vendor Certification

• Selection of materials for certification should also consider commercial aspects alongside criticality.
• Vendor selection should be based on factors like past supply history, quality trends, commitment to quality and delivery dates, compliance with quality parameters, pricing, and other commercial terms.
• A vendor certification team, comprised of people from various departments (e.g., quality control, quality assurance, production, and purchase), should be formed.
• In initial supplier contact, the supplier's manufacturing process, product specifications, process evaluation, changes to processes and specifications, and compliance of change control systems should be studied.
• A formal technical audit report on vendor performance must be carried out and delivered to management.
• Vendor certification or de-certification should happen in accordance with audit findings.

Raw Materials

• Supplier/manufacturer's name should be listed in approved vendor lists available in the receiving department.
• Received materials must be inspected for manufacturer/supplier name, product name, batch numbers, manufacture/expiry dates, quantity/packages, and condition.
• Relevant documents (invoice, customs/excise gate passes, CoA) are important to be verified prior to accepting the materials.
• All received raw materials must be quarantined immediately following arrival for sampling, testing and release.
• Containers should be cleaned externally and reported damages must be notified to the QC department.
• Containers must be protected from contamination in storage.
• Sampling must be carried out in dedicated cubicles by authorized QC personnel. Label containers accordingly.
• Containers from which samples have been taken and those from which partial amounts are supplied must be individually marked.
• Materials must be dispensed by authorized persons, in compliance with a written procedure, to ensure correct materials are accurately weighed and measured into clean, labeled containers.
• Correct material dispensing requires identifying name/category (e.g., BP/USP), analytical reference number (AR No), weight/measure, and batch number, for the product.
• All dispensed materials should be recorded in a logbook, chronologically, including product name/B number, time/date of dispensing, weigher/checker names.
• A QC person should independently verify weights, and a production supervisor should check before processing.
• Written standard operating procedures (SOPs) should include defining the authorized persons responsible for dispensing, and the precautions to be taken before dispensing (e.g., balance calibration, environmental conditions, and cleanliness).
• Verification of each item during weighing, correct weights/volumes recording, proper labeling, correct and complete filling of dispensing documentation, secure storage of dispensed materials (e.g., lockable stainless steel containers), and having a second person verify the dispensing are to be followed.
• After dispensing, materials must be returned to storage in properly closed/sealed conditions. The area and utensils should be cleaned.

Packaging Materials

• Packaging materials are categorized into primary, secondary, printed, and tertiary/other categories.
• Primary packaging comes directly into contact with the medicinal product (e.g., bottles, ampoules).
• Secondary packaging (e.g., labels, cartons) comes into contact with primary packaging.
• Printed packaging materials include labels and cartons with printed information.
• All packaging materials should be handled like raw materials (purchase, handling, and control).
• Printed packaging needs lock-and-key storage to prevent unauthorized access..
• Each batch or delivery unit of packaging materials should receive a specific identification mark or reference number.
• Outdated or obsolete packaging materials should be destroyed using appropriate procedures, documented, and under QA supervision.
• All products/packaging materials must conform to quality, identity, and quantity standards upon delivery to the packaging department.
• Detailed printed packaging records should be maintained indicating counting units.
• A detailed SOP should be available for dispensing packaging materials; only authorized personnel are allowed.

Intermediate and Bulk Products

• Intermediate/bulk products are materials that are processed but not yet finished products.
• Examples include granulated materials, compressed tablets, and liquids.
• Intermediate/bulk products should be stored under appropriate conditions (temperature, humidity, air class).
• The main/central warehouse manages raw, packaging, and finished products.
• Production departments are responsible for intermediate/bulk storage.
• Handling of intermediate/bulk products should be similar to raw materials on receipt.

Finished Products

• Finished products are packaged and ready for sale.
• Finished products should be quarantined until release.
• Each batch must be tested and meet specifications before release for distribution/sale.
• Finished products should be stored under manufacturer-specified conditions post release.
• Products not meeting specifications should be rejected.
• Reprocessing is permitted, only when feasible, and must meet all specifications before re-release.
• SOPs should define the authority, the necessary documents (e.g., BPCR, IPQC reports, finished product analysis, deviation reports, sterility reports, etc.), and the process to follow before releasing finished product batches.
• Partial batch releases are generally not appropriate unless a valid deviation is justified.
• A formal release report should be part of the BPCR.

Rejected Products

• Rejected materials are found not to meet specifications at any stage.
• Reprocess or send back to supplier.
• Rejection marking and disposal location should be clearly defined.
• Rejected materials should be stored in separate, designated areas (e.g., marked with RED).
• SOPs should define the materials identification, storage, record-keeping, and disposal procedures. Trend analysis on rejected materials is recommended.

Reprocessed Products

• Reprocessing happens when exceptional circumstances arise for rejected batches; must meet all specifications after reprocessing.
• The batch should be given a new number.
• A detailed record must be kept for reprocessed batches.
• Such batches must be separately monitored throughout shelf life.

Recovered Products

• Recovery is the addition of conforming earlier batch parts to a new batch from the same product at a pre-defined stage.
• Recovery should adhere to pre-defined guidelines (5-10%).
• Recovered material should meet the necessary specifications.
• Recovery should follow a predefined procedure; the evaluation of associated risks and shelf life impact should be performed.

Recalled Products

• Recalled products are those that were already delivered but need to be retrieved back. Reasons include (but are not limited to) substandard quality, emerging risks, or damage.
• Recalled products should be clearly identified and isolated in a secure area until the fate is decided.
• Returned products should be inspected by authorized personnel, and detailed evaluation should occur with the QC department. Reprocessing/recovery/destruction can be appropriate based upon the reasons for recall.

Reagents and Culture Media

• All reagents/culture media need to be tracked upon receipt or preparation.
• Lab-prepared reagents need to be prepared and labelled using written procedures.
• Labels should clearly include reagent name, concentration, standardization factor, shelf life, re-standardization date, storage conditions, and the preparer's signature/date.

Waste Materials

• Waste materials should be properly categorized (Trash/Scrap) before disposal.
• Different types of waste (paper, aluminum, plastic, glass, metal containers).
• Proper containers are required, and waste must be stored safely and removed regularly and in a sanitary way.
• Toxic/flammable materials must be stored per national legislation (e.g., in a fireproof cabinet).
• Dispensing and disposal of materials should be done meticulously.

Reference Standards

• Reference standards (official/primary) must be used as outlined in the relevant monograph.
• Producers create secondary/working reference standards, which need testing, release, and storage similar to official standards.
• All in-house standards should match official standards.
• Designated personnel should securely store them in designated areas.

Miscellaneous Materials

• Materials not categorized as RM/PM, intermediates, finished goods or pharmaceuticals are considered "miscellaneous."
• Examples include rodenticides, insecticides, fumigants, disinfectants, etc.
• Miscellaneous materials should not contaminate other materials or equipment.