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Thursday, October 19, 2017

Warning Letter due to Deficiencies in Filling System Design/Testing Particulate Matter













The US FDA has issued Warning letter in month of July 2017 to an Italian manufacturer of sterile products in Rome, due to deficiencies in the design of the filling system as well as the testing for particulate matter.

The FDA inspectors noticed that below deficiencies…

1.    Smoke studies in the filling area showed turbulent airflow. 
2.    There's no testing of the product for particulate matter before release.
3.    Sterility testing


The FDA now expects the manufacturer to identify all possible contamination risks in his aseptic production, including analyses of the facility layout, personnel and material flow, air systems and ergonomics of the equipment.

The FDA observations as below…

1.     Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).
2.     Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
3.     Sterility testing




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Monday, August 28, 2017

FDA Warning Letter | Bicooya Cosmetics Limited | GMP Violations











The U.S. Food and Drug Administration (FDA) has inspected drug manufacturing facility, Bicooya Cosmetics Limited at No. 17, Yan Hu Road, Shangxi Town, Zhejiang, from May 22–25, 2017.

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.


During our inspection, FDA investigator observed specific violations including, but not limited to, the following.

1.    Your firm failed to keep the buildings used in the manufacture, processing, packing, or holding of a drug product free of infestation by rodents, birds, insects, and other vermin (21 CFR 211.56(a)).

Investigator observed rodent feces throughout your facility:
·         in direct proximity to the filling machine where you manufacture OTC drug products
·         in direct proximity to the (b)(4) system, which produces (b)(4) incorporated in your drug products
·         throughout the warehouse, around both raw materials and finished drug products
Your over-the-counter (OTC) drug products include (b)(4) ointments and (b)(4).

2.    Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

For example, our investigator observed residue build-up in the (b)(4) tanks you use to manufacture OTC drug products, and damaged transfer hoses held together with plastic wrap. When an employee attempted to open a (b)(4) tank lid during the inspection, a hinge broke.

3.    Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
                                                                                                                             
You did not test all lots of your drug products for active ingredient content prior to release. You also failed to conduct microbial testing (i.e., total count, objectionable microorganisms) for each batch of drug product you release.Your firm stated that your customer only requires microbiological tests to be performed (b)(4). Because you lack microbiological testing, there is insufficient assurance that the products you distribute are safe and sanitary.

4.    Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).  

Investigator requested batch records for OTC drug product lots distributed to the United States, including (b)(4) Ointment and (b)(4). You were unable to provide batch records.

In addition, analytical testing records were missing data, dates, and signatures. Our investigator observed your staff altering information in analytical test reports during the inspection. For example, you significantly altered the analytical testing report for (b)(4) Ointment lot (b)(4), although this lot had already been distributed to the U.S. market.

CGMP consultant recommended

Based upon the nature of the violations FDA has been identified at firm that and strongly recommend engaging consultants qualified as set forth in 21 CFR 211.34, to assist the firm in meeting CGMP requirements. Use of consultants does not relieve your firm’s obligation to comply with CGMP. However firm executive management is remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.

Data Integrity Remediation

Firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.

Source: FDA


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Statement of Non-Compliance report with GMP Violations @ Dr.reddy's Lab










Dr. Reddy’s Laboratories on Thursday (Aug 10th) said the German regulator had not renewed GMP (good manufacturing practice) compliance certificate of its formulations manufacturing unit-2 in Bachupally, Hyderabad, following an inspection.

Pending revocation of the non-compliance notification, the plant will not be able to make any further dispatch to the European Union, DRL said in a stock exchange filing.

The drugmaker’s German subsidiary betapharm Arzneimittel GmbH had received a communication from the Regulatory Authority of Germany (Regierung von Oberbayern) on Wednesday (Aug 9th) night. The GMP compliance certificate in respect of the formulations manufacturing unit-2 plant in Bachupally is not renewed consequent to the recent inspection of the plant, the subsidiary had informed.

For the non-compliance notification to be revoked, another inspection would be required, which has to be initiated by an invitation from betapharm, DRL said.

The filing did not share details of violations leading to the certificate not getting renewed. A spokesperson of the company said the regulator had made some observations, details of which would be available once the document, in German, is translated.

Report for the Miryalaguda facility, which the company said indicated closure of the audit.



Source: The Hindu, EMA



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News questions and answers about safety features - Version 7 of the EU Q&As published













The European Commission published Version 7 of the questions and answers about safety features in June 2017. Compared to the previous version, eight new questions and answers have been added; also, six questions and answers have been revised. In total, the document now contains 65 questions and answers about safety features.
Question 1.15 has been newly added, for example, about whether there would be financial support for the implementation of safety features by the EU (or national). This question was negated.
Also newly added was question 2.14 about whether the Delegated Regulation would set guidelines on how the safety features should be applied to the outer packaging. The answer states that the Delegated Regulations do not contain any specific guidelines about the placement of the safety features on the outer packaging. It is therefore up the individual pharmaceutical manufacturer how he wishes to implement the safety features.
Question 1.2 confirmed the ambitious schedule. All European states with the exception of Belgium, Greece and Italy must have the newly-mandatory safety features implemented by February 9th, 2019.
Please also read version 7 of the questions and answers of the EU Commission about safety features for further details.


Source: Gmp compliance.org

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Saturday, July 29, 2017

USFDA observations beneficial in long run: Dr Reddy's India

Since November 2015, the company has significantly invested in processes, automation, detailed documentation of each batch and standard operating procedures and further strengthened its quality management systems.


Mumbai: US health regulator's observations are "unmistakably" beneficial in the long run and have helped the company accelerate the pace of quality reforms, pharma major Dr Reddy's Laboratories has said.
"The remedial actions triggered by the USFDA observations are unmistakably beneficial to us in the long run and it has helped us accelerate the pace of quality reforms across our plants. We believe that the shift in the US regulator's approach from 'what has gone wrong' to 'what can go wrong' is for the long term good of the industry," Dr Reddy's Labs Chairman K Satish Reddy said in the company's annual report.
Based on its corrective actions, the USFDA reinspected the company's three plants between February and April 2017. It had received some observations from the regulator thereafter and subsequently submitted a detailed response. The company is awaiting the USFDA's views on its latest set of responses.
Since November 2015, the company has significantly invested in processes, automation, detailed documentation of each batch and standard operating procedures and further strengthened its quality management systems.
However, the warning letter put on hold the company's approval of several key drugs, including high value added injectables and complex generics, to the US from the last quarter of 2015-16 and throughout 2016-17. This pipeline blockage affected revenues, margins and profits. Additional costs of conducting remedial work, including the use of international consultants, also reduced profits, he added.
Going forward, the drugmaker believes that the pricing pressures in the US market will be less severe and more calibrated in 2017-18. "We also have an excellent pipeline of complex generics to be introduced to the country in 2017-18 and expect to do better through this effective upgrade of our portfolio mix," Reddy said.
"We also believe that there are enormous opportunities across emerging markets and are playing actively to increase our presence in these territories through complex generics and biosimilars. The Russian and CIS markets are on a moderate upswing," Reddy added.
According to the pharma major, in the domestic market, threats of government-induced pricing pressure remain. "We are seeing greater offtake of generics - both relatively simple and complex - and oncological biosimilars, the latter through greater hospital and institutional sales. We believe that emerging markets will again get back to double-digit growth. Despite government induced pricing pressures on pharmaceutical products, India remains a high growth market," stated the report.
In 2016-17, revenues grew by 9 per cent over the previous year.
The first quarter of 2017-18, the chairman said, may see a temporary decline in sales due to de-stocking by trade on implementation of the Goods and Services Tax (GST). "Post normalisation, we expect to grow in low double digits in 2017-18 and for the foreseeable future," Reddy said.

Source: Economic Times India

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Tuesday, July 25, 2017

FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act (January 2017)













Just over three years ago, on November 27, 2013, Congress amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by enacting the Drug Quality and Security Act (DQSA). The first title of the DQSA, known as the Compounding Quality Act, was passed in response to numerous serious adverse events, including deaths, linked to poor quality compounded drugs. In particular, in 2012, injectable drug products produced by a compounder and shipped across the country caused a fungal meningitis outbreak that resulted in more than 60 deaths and 750 cases of infection, affecting patients in 20 states.

Compounded drugs can serve an important medical need for patients. However, if a compounded drug does not meet appropriate quality standards (e.g., if an injectable drug is contaminated, or if a tablet contains too much active ingredient), it could cause serious injury or death. Therefore, in implementing and enforcing the compounding-related provisions of the FD&C Act, FDA seeks to strike a balance between preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them while protecting patients from the risks associated with compounded drugs that are not produced in accordance with the applicable requirements of federal law.

FDA has devoted significant agency resources to implementing and enforcing the compounding-related provisions of the FD&C Act, including those added by the DQSA, in the wake of the 2012 fungal meningitis outbreak and other serious injuries and deaths.

Over the past three years,

FDA has:

• Significantly increased its inspections of facilities where drugs are being compounded and taken appropriate regulatory actions in response to violations of the law that put patients at risk;

 • Issued numerous policy documents, including draft and final guidance documents and proposed and final regulations;

• Convened advisory committee meetings to obtain advice on scientific, technical, and medical issues concerning drug compounding;

• Obtained input from stakeholders through a variety of different mechanisms; and


• Worked closely with states to share information and coordinate efforts.


The Regulatory Framework and History of Drug Compounding Regulation

Most prescription drugs are required to:

• undergo premarket approval to demonstrate safety and efficacy;

• be labeled with adequate directions for use so patients can safely use drugs for their intended purposes; and

 • be manufactured according to current good manufacturing practice (CGMP) requirements, which are intended to assure the identity, strength, quality, and purity of drugs by requiring adequate control of manufacturing operations.

These requirements provide important protections to patients. Under certain conditions, however, compounded drug products are not subject to these requirements. Other protections, such as the prohibition on preparing drugs under insanitary conditions, apply to all drug products, including compounded drugs.


What is Drug Compounding?

Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a sterile or non-sterile medication tailored to the needs of a patient. Compounded drugs are not FDA-approved.

A drug may be compounded for a patient who cannot be treated with an FDA-approved medication, such as a patient who has an allergy and needs a medication to be made without a certain dye, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form that is not otherwise available. Practitioners in hospitals, clinics, and other health care facilities sometimes administer or dispense compounded drugs to patients when an FDA-approved drug is not medically appropriate to treat them.

In these situations, compounding can serve an important patient need. However, some compounders engage in inappropriate compounding activities. For example, FDA is aware that some compounders produce drugs for patients even though an FDA-approved drug may have been medically appropriate for them. FDA has also observed that some compounders have advertised compounded drugs as safe and effective, sometimes for the treatment of serious diseases, incorrectly suggesting the drugs had met the standard for FDA approval.

Risks of Compounded Drugs

Because compounded drugs are not FDA-approved, FDA does not verify their safety, effectiveness, or quality before they are marketed. FDA also has observed that the labeling of compounded drugs often omits important information such as directions to help ensure that the drugs are used safely and warnings about possible side effects and drug interactions. In addition, and of particular concern, poor compounding practices can result in serious drug quality problems, such as contamination or medications that do not possess the strength, quality, and purity they are supposed to have. This can lead to serious patient injury and death.

In October 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history. A pharmacy in Massachusetts shipped contaminated compounded drugs to patients and health care providers throughout the country. The drugs, which were contaminated with fungal growth, were injected into patients’ spines and joints. More than 750 people in 20 states developed fungal infections, and more than 60 people died as a result. Approximately 14,000 patients received injections from the lots of contaminated drug product.


Source: FDA

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Monday, July 24, 2017

FDA Warning Letter | National Biological Corp | cGMP Violations










The United States Food and Drug Administration (FDA) conducted an inspection for National Biological Corporation 

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. FDA had received firm response, dated April 6, 2017, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued to the firm. FDA has address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following: 

1)    Failure to validate a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). Specifically,

a)  Two (b)(4) crimping press machines, five (b)(4) crimping applicator machines, and the (b)(4) crimping machine used to manufacture phototherapy devices have not been validated.

b)  The gluing/curing process used to manufacture the Dermalume 2x phototherapy device has not been validated.
FDA said..
Your response cannot be assessed at this time. Your response includes new validation procedures, protocol templates and a Validation Master Plan. Your plan states that the crimping processes and gluing & curing processes will be validated by June 30, 2017; all other processes requiring validation will be identified by June 30, 2017; the schedule, based on risk, will be established for all other processed that have been identified as requiring validation by August 30, 2017; and all validations will be completed by April 30, 2018.   Please provide an update on these corrective actions.

2)    Failure to establish and maintain procedures that address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90. 

a)  Specifically, your Nonconforming Material/Product procedures, QI-831 REV005, dated 02/27/2017 and QI-831 REV004, dated10/20/2016, do not assure all nonconformance’s receive an evaluation, which includes a determination of the need for an investigation. 
Nonconforming materials and products with a disposition of scrap, return to vendor or “use as is” are not evaluated to determine if an investigation is necessary. A total of 500 nonconformance’s with one of these three dispositions are listed in your 2016 NCR log and were not evaluated to determine if an investigations is necessary
b)  A total of 14 nonconformance’s listed in the 2016 NCM log do not have an initial or final disposition.

Your response is not adequate. Your response states the investigation conducted as part of CAPA 17-03 determined that your nonconformance procedure is inadequate in that it does not require an evaluation to determine if an investigation is necessary in all cases. You are revising your procedure and performing a retrospective review of all 2017 NCMs and remediating applicable investigations. A review of 4 months of records does not appear adequate. Typically, a 2 year retrospective review of records is performed. Please provide your rationale for reviewing only 4 months of records.

3)    Failure to establish and maintain procedures to assure that all complaints are reviewed and evaluated to determine whether an investigation is necessary, as required by 21 CFR 820.198(b).

Specifically, your Customer Complaint procedure, QI-853 Rev 001, dated 05/19/16 does not address evaluating all complaints to determine if an investigation is necessary, and complaints are only being assigned a complaint failure code and not being evaluated and investigated if there is a failure of the device.

Your response cannot be assessed at his time. Your response states that you will perform a retrospective review of the 2016 and 2017 complaint failure codes to determine if investigations are required. When required, investigations will be initiated and corrective actions taken. This review will be completed by June 1, 2017. Please provide an update on this corrective action.

4)    Failure to establish and maintain procedures for analyzing processes, work operations, concessions, quality audits, service records, complaints, returned product, and other sources of quality problems; and employing statistical methodology, where appropriate, to detect recurring quality problems, as required by 21 CFR 820.100(a).  

Specifically, complaint codes are assigned during the complaint evaluation but analysis of this data is not performed. Your Analysis of Data procedure, QI-841 Rev 000, was approved on 02/27/2017, but it has not been implemented.

Your response is not adequate. Your response states that you will perform a retrospective review of the 2016 and 2017 complaint failure codes to determine if investigations are necessary, but it does not address when you will be implementing your Analysis of Data procedure.

5)    Failure to have a complete risk analysis, as required by 21 CFR 820.30(g).

Specifically, potential hazards identified from post-market data for your phototherapy devices have not been incorporated into your risk analysis documents.

For example, Complaint 14107 describes a customer cutting their hand on your Handisol II photo-therapy device and Complaint 14426 describes a report of the external timer on the Dermalite therapy unit indicating hours and minutes instead of minutes and seconds. These hazards, sharp edges and incorrect timer readings, are not listed in the System Hazard Analyses Worksheet, PD-301, Rev 00, which is used to manage risk for these devices.

Your response cannot be assessed at this time. Your response provides documents showing that the hazards identified in the FDA-483 have been added to the appropriate risk analysis. You also state that the investigation conducted as part of CAPA 17-05 determined that your risk analysis procedures is inadequate. You state you will revise this procedure and will identify internal and external sources of post market data that require review for the risk management file. You also state that the last 12 months of complaints will be reviewed. Please provide the rationale for only reviewing 12 months of complaints to identify potential hazards that are not listed in your risk files. Also provide an update on the status of this corrective action.

6)    Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, Your Purchasing and Vendor Requirements procedure, QI-741, Rev 004, dated 11/3/2016, is inadequate in that :

a)  Consultants and contractors (test service lab) are not listed in your purchasing control procedures, and have not been evaluated; and requirements, including quality requirements have not been established, as required by 21 CFR 820.50.

b)  Quality requirements have not be established or evaluated for your high risk component suppliers, as required by 21 CFR 820.50(a). You have not required or evaluated processes at several suppliers that require validation of the process to manufacture the part/component. For example, parts/components have undergone processes such as injection molding, anodization and powder coating at the supplier and you do not require these processes be validated and have not included process validation during your evaluation.

c)  The type and extent of control has not been adequately defined for products based on evaluation results, as required by 21 CFR 820.50(a)(2). Specifically, your Purchasing and Vendor Requirements procedure does not describe the point values for any of your performance indicators nor does it describe the rating system associated with the assignment values.

d)  Consultants, testing services and off-the-shelf components used by your firm are not listed on your approved supplier list, as required by 21 CFR 820.50(a)(3).

Your response cannot be assessed at this time. Your response states you have opened CAPAs 17-06, 17-07 and 17-08 to investigate these violations. You are revising your procedures; reviewing the requirements for all suppliers; reevaluating critical suppliers; revising the monitoring and rating process for suppliers. Your response states all corrective actions will be completed by January 30, 2018. Please provide an update on the status of these corrective actions.

7)    Failure to document rework and reevaluation activities in the device history record, as required by 21 CFR 820.90(b)(2). Specifically,

A total of 3 of the 6 Nonconformance Reports that document rework for in-process nonconformances could not be linked to a device history record.

Your response cannot be assessed at this time. Your response states your investigation under CAPA 17-09 determined that rework is not being appropriately documented. The nonconforming product procedures and device history record procedure is being revised. The corrective action will be completed by June 30, 2017. Please provide an update on the status of these corrective actions.

8)    Failure to establish and maintain procedures to assure that equipment is routinely calibrated, inspected, checked and maintained, as required by 21 CFR 820.72(a).

Specifically, the heat gun used on the solder sleeve assembly for the DUSA phototherapy device has not been calibrated. It was not listed in the calibration log and there are no records of its calibration.

Your response cannot be assessed at this time. Your response states the heat gun will be calibrated and an impact assessment will be completed by May 1, 2017. It also states that that you will verify all tools and equipment are calibrated by September 1, 2017. Please provide an update on these corrective actions.

Our inspection also revealed that your firm’s Hand Foot II UVB-138 phototherapy devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:


Failure to submit any report required within 10working days of initiating such correction or removal, as required by 21 CFR Part 806.10. For example: On January 17, 2017, your firm conducted a recall on one work order of UVB-138 phototherapy devices because the lamps were incorrectly wired to turn on with the key rather than with use of the timer. The potential hazard associated with this device problem is overexposure of UV light, which can lead to skin burns. Your firm did not submit a written report to FDA of the medical device removal, as required by 21 CFR 806.

Source: FDA

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