Asia-Pacific Roundup: Pakistan finalizes GMP guidelines

The Drug Regulatory Authority of Pakistan (DRAP) has finalized its first set of consolidated guidelines on good manufacturing practices (GMP), overhauling a section on quality control since releasing a draft document last month.

While most of the final document remains unchanged from the earlier draft, DRAP made extensive revisions to the quality control requirements, rewriting and expanding its original stance and bringing its GMP rules into one document for the first time.

The final guidelines clarify that licensed companies need adequate facilities, trained personnel and approved procedures for sampling, inspecting and testing ingredients and finished products, as well as possess validated test methods and retain enough of their starting materials and products to “permit future examination.” DRAP has also added details on other basic quality control requirements that companies must meet.

Significant revisions were made to the control procedures subsection too. DRAP has provided information on the need to label samples with certain information and added lists of test requirements for starting and packaging materials, in-process control and finished products. The finished product section states that manufacturers can revalidate products that fail to meet established specifications and reject them if they fail again. Reprocessing is acceptable, provided the reprocessed product meets all specifications.

DRAP’s advice on control procedures now features discussions of production record and batch review and stability studies. The guidelines state that manufacturers must review production and control records and “thoroughly” investigate divergences or failures to meet batch specifications. On stability studies, DRAP is asking manufacturers to develop written programs for ongoing stability determination.

Subsections on self-inspection, quality audits, complaints and product recalls have been added, although the recall subsection reuses some text from the original draft. DRAP expects GMP manufacturers to “conduct repeated self-inspection” to evaluate compliance with all aspects of the production and quality control requirements, detect shortcomings and recommend corrective actions. As well as routine inspections performed at least once a year, companies can run ad-hoc self-inspections, for example, in response to a recall.

The final guidelines state that “it may be useful to supplement self-inspection with a quality audit” that examines all or part of a quality system “with the specific purpose of improving it.” A third party usually carries out the audit. The new quality audit subsection also covers the need for the quality control team to approve suppliers that “can reliably provide starting and packaging materials that meet established specifications.”

DRAP has made little to no changes to other sections of the guidelines, largely limiting its revisions to the updating of a reference to a Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the clarification of the relevant International Organization for Standardization documents. The guidelines are intended to ensure consistent compliance with quality standards and help regulators oversee GMP requirements.

Final Guidelines

Indonesia stops production of drug syrup after first case of acute renal disorder since December

The Indonesian Food and Drug Authority (BPOM) has ordered a temporary halt of production and distribution of a drug syrup linked to the first case of atypical progressive acute kidney disorder since December.

After contending with a wave of cases of kidney disorder in children last year, BPOM appeared to have stopped cough syrups contaminated with ethylene glycol and diethylene glycol from reaching patients.

In response to this new case, BPOM tested the patient’s remaining syrup, products from the same batch and adjacent batches, and samples of raw materials and other products made at the site. All the samples met the daily intake threshold requirements. BPOM also inspected the manufacturing facility and concluded that it meets good manufacturing practice requirements.

Despite that, the agency ordered manufacturing and distribution to stop as a precaution. A voluntary recall is underway. BPOM is now working with the Ministry of Health to identify the cause of the kidney disorder.

BPOM Notice (Indonesian)

WHO identifies gaps Timor-Leste needs to fill to be designated as a National Influenza Centre

The World Health Organization (WHO) has identified the gaps the Timor-Lest Ministry of Health needs to address to have its National Health Laboratory designated a National Influenza Center (NIC).

Timor-Leste has made “substantial advances in strengthening their influenza laboratory and surveillance capacities” by integrating their influenza and SARS-CoV-2 surveillance efforts and strengthening their sentinel surveillance network, WHO noted in response to the ministry’s request. WHO also highlighted the establishment of the national lab and its flu testing capabilities as the critical advance.

“Through the assessment, key areas for strengthening were identified, including addressing biorisk management, quality control procedures, and document management in the short-term, and equipment maintenance and calibration in the long term,” according to the WHO announcement. WHO will mentor staff at the Timor-Leste lab to help implement the recommendations and achieve NIC recognition.

WHO Statement

Safety signals spur TGA to advise against pregabalin in pregnancy

Australia’s Therapeutic Goods Administration (TGA) has advised physicians to prescribe pregabalin during pregnancy only “if the benefit to the patient clearly outweighs the potential risk to the fetus.”

In June, TGA found the product information for pregabalin, a treatment of neuropathic pain, generalized anxiety disorder and epilepsy sold under brand names including Lyrica, did not need updating as no firm conclusions could be drawn on its possible teratogenic effects. However, the results of a study of 2,700 pregnancies exposed to pregabalin in the first trimester have persuaded TGA to act.

The Lyrica product information now states that use of the drug “in the first trimester of pregnancy may cause major birth defects in the unborn child.” As such, TGA advises against use in pregnancy “unless the benefit to the mother clearly outweighs the potential risk to the fetus” and recommends that women of childbearing potential use effective contraception during treatment.

TGA Notice

Pakistan’s DRAP clarifies labeling requirements for complying with pharmacopeial specifications

DRAP’s registration board has cleared up confusion created by the presence of US Pharmacopeia (USP) monographs that describe the use of multiple dissolution tests.

USP addresses the situation in its materials, stating that manufacturers that use the first test do not need to name the test on the product label. The dissolution test only needs to be named if the company chooses one of the other tests. DRAP explained its interpretation of the rules.

“The manufacturer shall mention the dissolution test Number on the secondary packing/unit carton of product for dissolution tests No 2, 3 or 4 as per requirement of USP; otherwise, it would be presumed that dissolution test No.1 shall be performed on the finished product,” DRAP wrote.

DRAP Notice

Asia-Pacific Roundup: Pakistan finalizes GMP guidelines

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