Materials Management in Pharmaceuticals
97 Questions
0 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What is the prime objective of pharmaceutical manufacturing operations?

To produce finished pharmaceutical products from active and inactive raw materials, as well as packaging materials.

The quality of finished products solely depends upon the quality of the raw materials.

True (A)

What are the two main categories of materials used in pharmaceutical manufacturing?

Raw materials (RM) and packaging materials (PM).

What is the first step in the materials management process?

<p>Selecting vendors for raw materials (D)</p> Signup and view all the answers

All incoming materials should be quarantined immediately after receipt.

<p>True (A)</p> Signup and view all the answers

What information should be clearly defined on labels for each lot of RM/PM?

<p>All of the above (D)</p> Signup and view all the answers

What are the two primary methods used for stock rotation?

<p>First In - First Out (FIFO) and First Expiry - First Out (FEFO).</p> Signup and view all the answers

All materials and products should be stored under appropriate conditions established by the manufacturer.

<p>True (A)</p> Signup and view all the answers

It is okay to mix-up different materials during handling.

<p>False (B)</p> Signup and view all the answers

Bagged or boxed materials should be stored directly on the floor.

<p>False (B)</p> Signup and view all the answers

Written procedures should be available for all activities related to materials handling.

<p>True (A)</p> Signup and view all the answers

What is the main consideration when purchasing pharmaceutical materials?

<p>Quality.</p> Signup and view all the answers

All materials should be purchased according to an approved and adequate specification.

<p>True (A)</p> Signup and view all the answers

What factors should be considered when selecting a vendor for pharmaceutical materials, beyond quality?

<p>Price, delivery period, and consistency.</p> Signup and view all the answers

Materials should be purchased only from approved suppliers or manufacturers.

<p>True (A)</p> Signup and view all the answers

Who are the most suitable individuals to purchase RM and PM?

<p>Buyers who are trained and possess sufficient technical knowledge.</p> Signup and view all the answers

Materials managers with sufficient exposure to RM/PM for pharmaceuticals are considered appropriate persons for purchasing.

<p>True (A)</p> Signup and view all the answers

Industrial pharmacists with training in materials management are able to purchase RM and PM effectively.

<p>True (A)</p> Signup and view all the answers

What is the purpose of vendor certification in pharmaceutical manufacturing?

<p>To ensure that vendors consistently meet quality and regulatory standards.</p> Signup and view all the answers

What factors are considered for vendor material certification?

<p>All of the above (D)</p> Signup and view all the answers

What areas are typically represented in a vendor certification team?

<p>All of the above (C)</p> Signup and view all the answers

What are the key process components to be studied during the initial contact with a supplier?

<p>The supplier's manufacturing process, product specification and evaluation, and process evaluation.</p> Signup and view all the answers

Process and specification changes should be communicated to the supplier, even if they seem minor.

<p>True (A)</p> Signup and view all the answers

A formal technical audit report of the vendor should be prepared and shared with the management.

<p>True (A)</p> Signup and view all the answers

What are the two possible outcomes for a vendor based on audit findings?

<p>Certification or de-certification.</p> Signup and view all the answers

What should be checked for following information when receiving raw materials?

<p>All of the above (E)</p> Signup and view all the answers

Materials should be taken into account only after all relevant documents are available.

<p>True (A)</p> Signup and view all the answers

All received materials should be quarantined immediately after receipt.

<p>True (A)</p> Signup and view all the answers

What is the purpose of sampling raw materials?

<p>To determine the material's quality and suitability for use.</p> Signup and view all the answers

Sampling of received materials should be performed by QC personnel.

<p>True (A)</p> Signup and view all the answers

It is acceptable to store partially issued materials in multiple containers.

<p>False (B)</p> Signup and view all the answers

What is the main purpose of dispensing raw materials?

<p>To ensure the correct materials are accurately weighed or measured into clean and properly labeled containers.</p> Signup and view all the answers

Dispensing of raw materials should be performed by designated individuals following written procedures.

<p>True (A)</p> Signup and view all the answers

What information must be recorded in a register for all dispensed materials?

<p>The name of the product and batch number, time and date of starting and completion of the dispensing activity, and the names of the weigher and checker.</p> Signup and view all the answers

A QC person should independently verify the weights of dispensed materials.

<p>True (A)</p> Signup and view all the answers

What are the key points that should be covered in an SOP on dispensing materials?

<p>Persons authorized to requisition and dispense materials, precautions before dispensing, precautions during dispensing, and precautions after dispensing.</p> Signup and view all the answers

What are the four main categories of packaging materials used in pharmaceutical manufacturing?

<p>Primary, secondary, printed, and tertiary packaging materials.</p> Signup and view all the answers

Primary packaging materials come into direct contact with the medicinal product.

<p>True (A)</p> Signup and view all the answers

Secondary packaging materials directly contact the medicinal product.

<p>False (B)</p> Signup and view all the answers

Printed packaging materials are any packaging materials with something printed on them.

<p>True (A)</p> Signup and view all the answers

Tertiary packaging materials are all packaging materials other than the first three categories.

<p>True (A)</p> Signup and view all the answers

The purchase, handling, and control of primary and printed packaging materials should be the same as for raw materials.

<p>True (A)</p> Signup and view all the answers

Printed packaging materials should be stored securely in a lock and key system to prevent unauthorized access.

<p>True (A)</p> Signup and view all the answers

Each delivery or batch of primary packaging materials must have a specific reference number or identification mark

<p>True (A)</p> Signup and view all the answers

Outdated and obsolete primary and printed packaging materials should be destroyed using a suitable and approved method.

<p>True (A)</p> Signup and view all the answers

The destruction of printed packaging materials should be done under the direct supervision of a responsible person.

<p>True (A)</p> Signup and view all the answers

All products and packaging materials to be used should be checked on delivery to the packaging department.

<p>True (A)</p> Signup and view all the answers

Quantitative records for printed packaging materials should be maintained to the last counting unit.

<p>True (A)</p> Signup and view all the answers

A detailed SOP should be available for dispensing packaging materials and only authorized personnel should be involved.

<p>True (A)</p> Signup and view all the answers

A separate sampling room should be dedicated for sampling primary packaging materials.

<p>True (A)</p> Signup and view all the answers

What is an intermediate or bulk product in pharmaceutical manufacturing?

<p>A material that has begun processing but has not yet been converted into a finished, saleable product.</p> Signup and view all the answers

Intermediate or bulk products should be stored under the same conditions as finished products

<p>False (B)</p> Signup and view all the answers

What department is typically responsible for managing the storage of intermediate and bulk products?

<p>The production department.</p> Signup and view all the answers

Intermediate or bulk products purchased as such should be handled the same as raw materials.

<p>True (A)</p> Signup and view all the answers

Finished products are considered to be in the marketable pack.

<p>True (A)</p> Signup and view all the answers

Finished products are immediately released after being packaged.

<p>False (B)</p> Signup and view all the answers

Each batch of finished products should be tested according to a laid-down procedure before release.

<p>True (A)</p> Signup and view all the answers

Finished products are stored as usable stock under conditions established by the manufacturer following release.

<p>True (A)</p> Signup and view all the answers

Products failing to meet specifications or other quality criteria should always be reprocessed.

<p>False (B)</p> Signup and view all the answers

A formal report or certificate of release should be prepared for each batch of finished products and become part of the Batch Production and Control Record (BPCR).

<p>True (A)</p> Signup and view all the answers

Partial batch release is generally an acceptable practice.

<p>False (B)</p> Signup and view all the answers

What is a rejected material?

<p>A material that has been tested and found to not meet predetermined specifications fully.</p> Signup and view all the answers

What are two ways to deal with rejected materials?

<p>Reprocess and retest (A), Destroy or send to the supplier (C)</p> Signup and view all the answers

Whatever action taken regarding rejected materials should be approved and documented.

<p>True (A)</p> Signup and view all the answers

Rejected materials and products should be clearly marked and stored separately in restricted areas.

<p>True (A)</p> Signup and view all the answers

Restricted areas for rejected materials are typically painted red to make them easily identifiable.

<p>True (A)</p> Signup and view all the answers

What are the key points that should be covered in an SOP on handling rejected materials?

<p>How rejected materials are identified, stored, disposed of, and the precautions to avoid accidental use.</p> Signup and view all the answers

A trend analysis report of rejected materials can be helpful in identifying reasons for rejection and taking corrective action.

<p>True (A)</p> Signup and view all the answers

Reprocessing of rejected production batches is always recommended.

<p>False (B)</p> Signup and view all the answers

Reprocessed batches should be given a new number for identification.

<p>True (A)</p> Signup and view all the answers

Reprocessed batches should be monitored separately throughout their shelf life.

<p>True (A)</p> Signup and view all the answers

What is recovery in the context of pharmaceutical manufacturing?

<p>The addition of all or part of earlier batches, conforming to the required quality, into a new batch of the same product at a pre-defined stage of manufacture.</p> Signup and view all the answers

Normally, up to 15% of recovery can be added to a fresh batch.

<p>False (B)</p> Signup and view all the answers

Recovery should only be carried out after a thorough evaluation of the potential risks including any impact on product shelf life.

<p>True (A)</p> Signup and view all the answers

All recovered materials should be authorized and recorded.

<p>True (A)</p> Signup and view all the answers

What are the common reasons for product recalls?

<p>Substandard quality detected after distribution, emerging risk or potential toxicity, and damage of goods during transit.</p> Signup and view all the answers

Recalled products should be clearly identified and stored separately in a secure area until a decision is made on their fate.

<p>True (A)</p> Signup and view all the answers

What are some possible actions taken with recalled products?

<p>All of the above (E)</p> Signup and view all the answers

Reprocessing and recovering recalled products is always possible.

<p>False (B)</p> Signup and view all the answers

Reprocessed and recovered recalled products may be considered for re-labeling and repackaging

<p>True (A)</p> Signup and view all the answers

All reagents and culture media should be recorded upon preparation or receipt.

<p>True (A)</p> Signup and view all the answers

Reagents made up in the laboratory should be prepared according to written procedures and appropriately labeled.

<p>True (A)</p> Signup and view all the answers

What information should be included on reagent labels?

<p>All of the above (H)</p> Signup and view all the answers

Pharmaceutical operations generate a significant amount of waste materials.

<p>True (A)</p> Signup and view all the answers

What are the two main categories of waste materials?

<p>Trash and scrap.</p> Signup and view all the answers

Waste materials should be segregated into different categories before disposal.

<p>True (A)</p> Signup and view all the answers

Waste materials should be allowed to accumulate until disposal.

<p>False (B)</p> Signup and view all the answers

Toxic substances should be stored in a securely enclosed cupboard.

<p>True (A)</p> Signup and view all the answers

Flammable solvent drums should be washed thoroughly before disposal.

<p>True (A)</p> Signup and view all the answers

Reference standards may be available in the form of official (primary) reference standards.

<p>True (A)</p> Signup and view all the answers

Official reference standards should be used only for the purpose described in the appropriate monograph.

<p>True (A)</p> Signup and view all the answers

Secondary or working reference standards should be tested and released before storage following the same procedures as official standards.

<p>True (A)</p> Signup and view all the answers

All in-house reference standards should be based on official reference standards whenever possible.

<p>True (A)</p> Signup and view all the answers

Reference standards should be stored under the responsibility of a designated person in a secure area.

<p>True (A)</p> Signup and view all the answers

Materials that do not fall under the categories of RM, PM, intermediates, bulk, or finished pharmaceuticals are considered miscellaneous materials.

<p>True (A)</p> Signup and view all the answers

Rodenticides, insecticides, fumigating agents, and sanitizing materials are considered miscellaneous materials.

<p>True (A)</p> Signup and view all the answers

Miscellaneous materials should not contaminate other materials or products.

<p>True (A)</p> Signup and view all the answers

Study Notes

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.

Studying That Suits You

Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

Quiz Team

Related Documents

Pharmaceutical Materials Management Chapter 3 PDF

Description

Explore the critical aspects of materials management in pharmaceutical manufacturing. This quiz covers the processes involved from vendor selection to product delivery, emphasizing the importance of material quality and storage procedures. Test your knowledge on handling, labeling, and storing raw and packaging materials.

More Like This

Use Quizgecko on...
Browser
Open
Browser
Browser