GMP module 05 - Role of Warehouse in GMP

Outcome of the Module:

The quality of a pharmaceutical product is defined as one that is pure, correctly identified, effective and safe to use. Customers and patients have an ethical (and legal) right to expect quality pharmaceutical products. 

The warehouse plays a pivotal role in manufacturing quality products, as it is responsible for all incoming goods (including labeling and packaging) and for releasing finished products. Therefore, there are GMP rules in place to ensure that materials are handled and stored properly, while appropriate documentation is maintained.

By the end of this module, you will be able to:

  • Explain the role of the warehouse
  • List the GMP procedures needed in the warehouse to control incoming goods
  • Identify the GMP requirements for handling starting materials and finished products in the warehouse
  • Recognize the GMP issues surrounding release of finished products to the marketplace
  • Recognize issues around transport of goods to and from the public
  • Recognize how returns ore handled by the company
  • Identify the different documentation needed in the warehouse

 

Part I: Role of the Warehouse

Once a finished product is received into the warehouse, it does not undergo any further inspections or quality control tests. If the product is degraded or damaged at this point, there is nothing that stops it from being given to the patient. The warehouse must rely upon procedures and well-trained staff to ensure that products arrive safely and with the same quality as when they left manufacturing.

There have been many cases of product being affected by poor warehouse storage conditions or rough handling on transport. Biopharmaceutical products often have temperature-sensitive active ingredients that break down or degrade if exposed to heat or light, thus becoming ineffective.

A pharmaceutical warehouse must be expertly managed and run in compliance in order for the company to protect and distribute a quality product.

These compliant practices include control over receiving goods, quality control, storing materials, components and products, fulfilling picking requests and shipping the product to the marketplace.

These practices must be completely traceable in order to protect the integrity and stability of the product and its packaging.

  • GMP rules for the warehouse enable manufacturers to:
  • Protect medicines from damage during storage and transport
  • Prevent degradation of the product by exposure to adverse temperature conditions
  • Avoid mix-ups and contamination by other materials
  • Maintain product identity and traceability
  • Prevent time-expired or damaged material or product from being used

 

Part II: GMP Warehouse Rules

A fundamental GMP control is to ensure that only approved starting materials that meet specifications are used to formulate medicines. Patient safety depends on it. Removing the protection of status controls will raise the risk of an error occurring. 

The government regulatory agencies and their auditors are very aware that lack of control over material movement in the warehouse can, and has, led to defective product. For this reason, they regularly conduct inspections of the warehouse and the warehouse procedures to ensure that GMP rules are in place.

Preventing contamination and mix-ups of materials and products are the main focus of GMP in the warehouse. Some general rules to prevent contamination and mix-ups are:

  • Materials must be purchased only from approved suppliers to written specifications.
  • All incoming materials must be placed into quarantine.
  • Quarantined materials must be inspected and/or tested to verify their suitability for use.
  • All materials must be labeled clearly to indicate their inspection and test status.
  • Materials must be stored safely to protect from deterioration and damage.
  • Records must be maintained for all issued material in order to ensure traceability.

 

Part III: Receipt and Issue to Manufacturing

Many mis-formulation incidents commence with the wrong issue of starting materials or other chemicals from the store.

The GMP rules clearly state that each issue of starting materials from the store must be accompanied by requisition paperwork and that there is a cross-check that issues match the documented request before being issued.

The reason for this requirement is that material issue is the first point of control inside the factory. It is much better to prevent incorrect chemicals being issued in the first place rather than finding them (or not) later on. Mis-formulation can cause patient medication to be unsafe, which can result in serious injury or even death of patients.

One of the most important aspects of GMP is to ensure that the right raw materials are received and that the correct raw material batch is issued to production to commence manufacture.

Mistakes in this activity can have significant consequences for patient safety, or cause batches to be rejected. Therefore, the utmost care must be taken when receiving, logging in, storing, and issuing of raw materials.

Part IV: Finished Product Release

Customers of pharmaceutical products expect to receive a product that is not only manufactured and packaged correctly but also one that arrives in good condition. Warehousing, transport, and distribution procedures play a vital part in protecting the product all the way to the customer.

Invoices or packing slips should be issued for each delivery and should accompany the goods.

Records should be maintained in such a way that they are clear and readily available. Records should show the receipt and disposal of all products purchased and sold.

Distribution records should be kept in a form which is accessible to the regulatory authorities.

Part V: Handling Returns

Once a product leaves the control of the warehouse, it is subject to the possible impact of transport mistakes and uncontrolled warehouse conditions. Many medicines can degrade if heated or frozen even for short periods of time. These issues particularly apply to biological products, vaccines and products that are labeled: “Store 2°C – 8°C. Do not freeze.”

For example, product that is required to be stored at 2°C – 8°C may degrade if it was stored at more than 1°C for any period of time. If the product was frozen and then thawed, it would be very hard to detect this physically, and it may make the product unusable.

GMP rules require that returns be assessed formally before any decision is made to return them to stock.

Customers may return stock because it is oversupplied or incorrectly delivered. However, it is not safe to assume that stock could be suitable for re-sale. There is generally no way to tell whether the return has been tampered with, degraded in transport or storage, or has been damaged in transit.

GMP rules require that all returns be examined by the Quality Department and if necessary re-tested, before they can be placed back into stock. In some cases, if there is no way to tell if returned products have degraded, they must be destroyed.

Products earmarked to be reissued must be kept separate from the rest of the stock until they are investigated. They may be returned to stock, only if the goods:

  • Are in their original containers, unopened, and in good condition
  • Are known to have been handled and stored correctly
  • Have an acceptable shelf-life remaining
  • Have been assessed by the appropriate, authorized personnel

 

Records must be kept of these returns, and if they are returned to stock, FIFO must continue to be observed. Medicines that are unfit for sale must be stored separately and disposed of in a secure method (e.g. incineration).

Part VI: GMP & Documentation

A mix-up of sodium chloride and potassium chloride may be undetected by the laboratory, but could have fatal consequences for patients injected with the wrong salt.

GMP rules require that there is extensive record keeping on the receipt, testing, storage, issue, and use of starting materials for this very reason. Without accurate and detailed records in the warehouse, it may not be possible to investigate a problem quickly or thoroughly. Any delay may cause additional problems for patients. Certainly in the case of a recall the size of the recall will be determined by the accuracy and completeness of the warehouse records.

Conclusion:

This module highlighted the importance of the warehouse in the day-to-day activities of the pharmaceutical manufacturer. The warehouse plays a crucial role in the manufacture of quality products. 

Warehouse staff must abide by GMP rues to prevent goods from being contaminated, mixed up, or degraded, and issuing the right material:

Maintaining proper housekeeping, and storing the right goods in the right locations.

  • Protecting goods from pests and maintaining appropriate air and temperature controls for the goods.
  • Only issuing materials to manufacture that have been approved by QC.
  • Adhering to FIFO principles in issue to manufacture and dispatch to customer.
  • Having procedures for managing recalls.
  • Maintaining accurate documentation.

 

Online Quiz:

Online Quiz:

  • Number of questions: 10
  • No time limit
  • Allow you save and finish at a later date
  • Allow you to go back and change your answer
  • Attempting each question is mandatory
  • Pass mark at and above 70%
  • Print results and certificates
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