Drug product recalls

The following are examples of some of the typical violations leading to drug product recall according to the FDA ... 

Procedures and plans supporting business continuity (Disaster Recovery Plans and Contingency Plans) must be specified, tested, and approved before the system is approved for use. Business Continuity Plans will normally be prepared for a business or an operational area rather than for individual computer systems. It is likely that the only way to verify the plan is to walk through a variety of disaster scenarios. Topics for consideration should include catastrophic hardware and software failures, fire/flood/lightning strikes, and security breaches. Alternative means of operation must be available in case of failure if critical data is required at short notice (e.g., in case of drug product recalls). Reference to verification of the Business Continuity Plans is appropriate during OQ/PQ. 

I. Request that the manufacturer initiate a drug product recall... 

Drug product recall of 60 million tablets of the blood pressure medication Avalide, a combination of two anti-hypertensives, hydrochlorothiazide and irbesartan. Concerns were over possible variability in the amounts of the less soluble polymorph of irbesartan, which may result in slower dissolution. 

A review of complaints, recalls, returned or salvaged drug products, and investigations conducted under 211.192 for each drug product. 

Many in the pharmaeeutieal industry will recall the Wall Street Journal artiele that deelared the manufacture of potato ehips more teehnologieally advanced than the manufacture of pharmaeeutieals." This may seem a harsh criticism, but it is honest. Dissolution has been used to test drug product quality since the... 

Chapter 7 of the Regulatory Procedures Manual (March 2007, available at www.fda. gov) provides detailed instructions to FDA personnel regarding recalls. The FDCA does not authorize the FDA to order a manufacturer to recall a drug product.11 In practice, however, the manufacturers or distributors of the drug products are encouraged to implement and carry out recalls voluntarily to fulfill their responsibility to protect the public. It is not uncommon for a company to discover that one of its products is defective and recall it entirely on its own or the FDA informs a company of its findings that one of its products is defective and suggests or requests... 

Class I recalls involve drug products in which the reason for recall predictably could cause serious health problems or death. 

Class II recalls involve drug products which defect might cause a temporary health problem or pose only a slight threat of a serious nature. 

As shown in Table 10 New Zealand s own GMP code consists of five parts. The first part covers the manufacture of drug products and the second part the manufacture of blood products. Part 3 covers compounding and dispensing, including compounding of sterile drug products. Part 4 deals with wholesaling and Part 5 with product recalls. Parts 4 and 5 are combined in one document [31]. 

Toxic Decomposition Products In situations where the content of the API in a drug product is well above 90% as indicated above, the formation of toxic degradation products within the shelf life (which may cause untoward effects to the patients) may warrant the reassignment of a different expiration date or recall of the drug product in question. Consequently, the pharmaceutical industry is often concerned with both the amount as well as the nature of the degradation products. The formation of toxic products is particularly problematic with protein drugs which may maintain therapeutic activity after deliberate modification or pertubation of molecular structure in a domain removed from that associated with therapeutic activity... 

There are no additional or reduced regulatory requirements for closing sites. Computer systems should be maintained in a validated state of compliance up until the very last day of their operational life. GxP records must be archived and stored for the required retention periods. Archived records should be readily retrievable to support critical quality operations like recall, customer complaints, and batch investigation. Computer systems should then be decommissioned, as discussed later in this chapter. Some computer systems may be disassembled and sent for installation at other sites as part of a program of drug product transfers. 

Inventory records need to account for samples withdrawn for stability, expiry, or shelf-life checks. Depending on the allowable tolerances for controlled drugs, such sampling, if not recorded properly, can lead to unacceptable levels of unaccounted stock in the event of a product recall being initiated. Sample request or receipt forms may be transmitted photographically or electronically, for example by facsimile transmission (FAX) or electronic data transfer, provided that the method of transfer meets the security requirements outlined in 21 CFR Part 203. Computer systems used to manage or record the distribution details for samples held by manufacturers or distributors representatives also require validation. 

The average number of recalls per annum for microbial contamination of non-sterile pharmaceutical and OTC drug products is six (Table 4). The emphasis on waterborne Gram-negative bacteria of the species Bulkholderia (Pseudomonas) cepacia (nine recalls), P. putida (three recalls), P. aeruginosa (three recalls). Pseudomonas spp. (two recalls), and Ralstonia (P.) pickettii (one recall) is notable and reflects the concern for bacteria capable of growth in liquid oral dosage forms that overwhelm the preservative system. 

Each year before October 1, the applicant has to notify the TPP on a prescribed form that the data submitted for a particular drug are still valid and correct. The DIN can be cancelled if the drug is no longer sold if it is determined that the product is not a drug or if the drug is recalled for a number of reasons, listed later. 

Drug registration, coupled with efficient and effective post-marketing surveillance, provide the Ministry of Heeilth with a means to control the quality, safety and efficacy with the introduction of medicinal products into Singapore. Drug registration also provides for a more effective system of product recall in cases of detection of defective or drugs harmful to public health. 

Care should be exercised by members that the distribution of samples is carried out in accordance with the law and regulations issued by the State Institute for Drug Control (SUKL). Samples may be supplied to physicians only for becoming familiar with products. Representatives must take adequate precautions to ensure the security of samples in their possession. Members must develop an appropriate recording system so that, if a product recall is necessary, relevant samples will be included in the recall. On request, members must promptly accept the return of samples of their products. 

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