Asia-Pacific Roundup: Malaysia’s NPRA posts analysis of GMP deficiencies

Malaysia’s National Pharmaceutical Regulatory Authority (NPRA) has released an analysis of the good manufacturing practice (GMP) inspections it conducted at home and abroad last year, revealing trends in the types of deficiencies identified by its staff during routine assessments of production facilities.

Last year, NPRA conducted 52 GMP inspections of pharmaceutical facilities, two of which were found to be unacceptable and faced regulatory actions. NPRA divided its analysis of the deficiencies identified by its inspectors based on the Pharmaceutical Inspection Co-operation Scheme’s (PIC/S) guide to GMP for medicinal products.

Inspectors discovered critical deficiencies related to four of the guide’s chapters: pharmaceutical quality system (PQS), personnel, premises and equipment, and production. The number of critical deficiencies seen in 2022 was split fairly evenly across the chapters, with three problems related to PQS and two for each of the other chapters, but NPRA zeroed in on four GMP requirements across three chapters as areas in which critical and major deficiencies frequently occur.

The PQS itself is one area in which NPRA has repeatedly seen compliance failings. In its analysis of the GMP inspection findings, the Malaysian regulator said, “Manufacturers need to pay attention on the design and implementation of PQS,” adding that the system is needed to “ensure the medicinal products produced are fit for their intended use, comply with the requirements of marketing authorization and do not place patients at risk due to inadequate safety, quality and efficacy.”

NPRA listed specific elements that make up the PQS, such as having “sufficiently qualified personnel to carry out all the tasks” and outsourced activities that are “appropriately defined, agreed and controlled in order to avoid misunderstandings.”

The agency provided similar overviews for the three other areas in which it has frequently seen major and critical findings. The two problematic clauses of the personnel chapter describe the need for training of all personnel, including technical, maintenance and cleaning staff, who enter production and storage areas or control laboratories, and the requirement for every person in manufacturing areas to wear “protective garments appropriate to the operations to be carried out.”

“The availability, suitability and the cleanliness of the garments should be emphasized. The handling of used garments and laundry activities also need to be improved to ensure the garments used will not pose any risk of contamination to the operations and products,” NPRA wrote.

In the production chapter, NPRA highlighted a clause about preventing cross-contamination through the design of the premises and its equipment, factors that are described in another chapter. The agency listed eight measures that manufacturers could take to minimize the risk of cross-contamination, such as having a “self-contained production area on campaign basis followed by a validated cleaning process” and “validated cleaning process of equipment.”

The three chapters singled out by NPRA cover almost 80% of the critical deficiencies and almost half of the major failings identified last year. NPRA excluded the chapter on premises and equipment from the analysis of the most frequent failings despite it being the cause of two of the nine critical deficiencies and 30% of the major failings seen in 2022. The chapter also had the most minor deficiencies, 320.

NPRA noted the level of Chapter 3 deficiencies in its conclusion, stating that the figures show “the area requires some attention and improvement activity from the manufacturer in order to avoid any risk to the products.” The agency also said Chapter 5 (production) and 6 (quality control), “are two additional areas for the manufacturers to look at.”

NPRA Notice

Australia’s TGA prepares for the imminent end of the ingredient dual labeling period

Australia’s Therapeutic Goods Administration (TGA) has shared details of what will change when the dual labeling period ends for most names on 30 April.

Currently, some products sold in Australia are listed by two names on their labels and in their Product Information and Consumer Medicines Information documents. TGA adopted the model to give people time to get used to new names that are used internationally. Lidocaine, for example, has been labeled as “lidocaine (lignocaine)” to help move to the new name without confusing people used to the old name.

At the end of April, the dual labeling period will cease for most products. After that, medicines that only feature one name, for example “lidocaine” will start to appear. Sponsors have three years to update labels to only show the new name of the ingredients. TGA is asking healthcare professionals to take care when prescribing medicines to ensure that the right product is selected.

TGA Notice

China downgrades COVID reimbursement but will support people struggling to pay for drugs

China has downgraded its COVID-19 insurance reimbursement management level but will give financial help to people who are struggling to pay for some treatments.

Under the new policy, medical bills for the treatment of COVID-19 will be reimbursed by China's health insurance fund in the same manner as other Class B infectious diseases. China lowered its management of COVID-19 from Class A to Class B at the start of the year but also introduced a temporary medical insurance reimbursement policy that covered six antiviral drugs, including Pfizer’s Paxlovid.

The new policy completes the transition to the Class B management level. The only difference is that the system will provide financial assistance for “COVID-19 patients who are still struggling to pay for treatments that have been covered by basic insurance plans and those that specifically focus on major diseases.”

NMPA Notice

TGA issues recall notice after consumer finds metal fragment in chewable tablet

TGA has shared details of a BioCeuticals’ recall triggered by a consumer’s discovery of a metal fragment in a chewable tablet.

The recall covers a single batch of the manufacturer’s Ultra Potent-C Chewable vitamin C supplement. A consumer “found a small fragment of metal about the thickness of a human hair embedded in a tablet.” No serious injuries resulted from the incident but, because “small pieces of metal like the one found could cause injuries to the mouth and digestive tract,” BioCeuticals is recalling the rest of the batch.

An internal investigation by BioCeuticals found “the metal fragment was likely to be from the manufacturing process.” Neither TGA nor BioCeuticals have received other reports about metal fragments in the product.

TGA Notice

India updates list of approved fixed-dose combinations after discovering errors in original text

India’s Central Drugs Standard Control Organization (CDSCO) has updated its list of approved fixed-dose combination (FDC) products after discovering “certain typographical” errors in the original document.

In February, CDSCO published an update on its scrutiny of FDCs, a process that has now been going on for a decade. The notice featured several annexes, including one that listed the FDCs that the Indian government has approved “in a phase wise manner based on phased scrutiny and recommendations by Kokate Committee,” the body set up to assess the rationality of drug combinations sold in the country.

The new notice reissues the annex of approved FDCs. CDSCO took the action to correct errors in five of the more than 2,100 FDC products listed in the annex.

CDSCO Notice

Asia-Pacific Roundup: Malaysia’s NPRA posts analysis of GMP deficiencies

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