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Monday, May 18, 2020

FDA Guideline to 21 CFR PART 211 SUB PART-D EQUIPMENT #21CFR #PART211 #EQUIPMENT #PBS #PBSINDIA

Leo Group India8:02:00 AM211 CFR, FDA, FDA Guide No comments

FDA Guideline to 21 CFR PART 211 SUB PART-D EQUIPMENT #21CFR #PART211 #EQUIPMENT #PBS #PBSINDIA

GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal. (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed/ experts experiences sharing.) Disclaimer: The Logos/Images & content posted here are belongs to respective to Authority / owners of firm. The Article posted under public health importance news. Please ensure the guideline as per Regulatory agencies.

FDA GUIDE TO 21 CFR PART 211 AND SUB PARTS #FDAGUIDE #21CFR #PART211 #FORMULATIONS #GMP #PHARMAGUIDE

Leo Group India7:29:00 AM21cfr, FDA, FDA Guide No comments

FDA GUIDE TO 21 CFR PART 211 AND SUB PARTS #FDAGUIDE #21CFR #PART211 #FORMULATIONS #GMP #PHARMAGUIDE

FDA Warns Drug Facilities in China, Ireland, Australia and India

Leo Group India3:25:00 AM2018, FDA, Mahender, May18, Warning Letters 1 comment

FDA Warning Letters go to Manufacturers in China, Ireland, Australia and India

In the Month of May-2018 The US FDA has issued Warning Letters to pharmaceutical firms which not address cGMP practices

The drug facilities are:

Jilin Shulan Synthetic Pharmaceutical und Nox Bellcow Cosmetics Co, China
Jalco Cosmetics, Australia
Europharma Concepts, Ireland
Reine Lifescience, India.

The five manufacturers were placed on FDA import alert until the complete correction of all violations. Here are some of the findings:

Jilin Shulan Synthetic Pharmaceutical, China

During the four-day inspection, a number of GMP violations were detected. These included a lack of documentation for deviations, insufficient data-protection controls as well as record-keeping delays during manufacturing operations. Especially the integrity of data and the well-functioning of the quality unit were questioned. It was found that operators were able to modify and delete files on the firm’s systems. Therefore, the quality of the manufactured drugs was considered insufficient. It also appeared evident that the staff had no knowledge of GMP.

Observations:

1. Failure to document known deviations and out-of-specification results and conduct a thorough investigation.

2. Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data.

3. Failure to record activities at the time they are performed.

Jalco Cosmetics, Australia

Observations:

1. 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)).

2. Your firm failed to test samples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality (21 CFR 211.84(d)(1) & (2)).

3. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

4. Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products. (21 CFR 211.166(a)).

The FDA concludes that they “recommend a qualified third party to perform a comprehensive audit of the entire operation for cGMP compliance, including the quality assurance system, materials system, facility and equipment system, laboratory system, production system, and packaging and labelling system. CAPA should then be evaluated by the third party to help ensure systemic remediation before pursuing resolution of your firm’s compliance status.”

Europharma Concepts, Ireland

Observations:

1. Your firm failed to test samples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality (21 CFR 211.84(d)(1) and (2)).

2. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a))

Reine Lifescience - India

Observations:

1. Failure to validate and verify the suitability of analytical methods.

2. Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data.

3. Failure to adequately validate written procedures for the cleaning and maintenance of equipment

www.gmpviolations.com GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal. (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed/ experts experiences sharing.) Disclaimer: The Logos/Images & content posted here are belongs to respective to Authority / owners of firm. The Article posted under public health importance news. Please ensure the guideline as per Regulatory agencies.

Alembic Pharma gets three observations from US FDA for Gujarat plant

Leo Group India10:33:00 AM2018, 483, FDA, Mahender, Mar18 No comments

Alembic Pharmaceuticals said none of the observations are related to data integrity or repetitive in nature

Alembic Pharmaceuticals said the US health regulator has made three observations after inspecting its formulation facility in Panelav, Gujarat.

“The United States Food and Drug Administration (US FDA) has conducted an inspection at Alembic Pharmaceuticals formulation facility located at Panelav from March 12-20, 2018. This was a scheduled inspection and at the end of the inspection, the US FDA issued a form 483 with 3 observations,” the company said in a regulatory filing.

Alembic Pharmaceuticals said none of the observations are related to data integrity or repetitive in nature. “The company is preparing the response to the observations, which will be submitted to the US FDA shortly,” it added.

As per the US FDA, a Form 483 is issued to a firm’s management at the conclusion of an inspection when investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company’s management of objectionable conditions.

Source: Expressbpd

FDA has issued form 483 to Dr. Reddy's Laboratory | API | IDA Bollaram | GMP VIOLATIONS |

Leo Group India10:46:00 AM2018, 483, Dr.Reddy's, FDA, Mahender, Mar18 No comments

FDA has insured form 483 to Dr. Reddy's Laboratory | API | IDA Bollaram | GMP VIOLATIONS |

The US FDA has been inspected the Dr. Reddy's laboratory located at IDA Bollaram which is manufacturing of Active pharmaceutical ingredients. The form 483 has been issued with 5 observations.

OBSERVATION 1:

The responsibilities and procedures applicable to the Quality control unit are not fully followed. Specially

A) Your quality unit failure to close multiple CAPAs within allowable timeframe and justification to extend the completion timeframe was not requested. Specifically, your quality unit did not request an extension to the few CAPAs.

B) One of QC laboratory Audit trail reviewed and found discrepancy which is having without logging incident. And proper justification found.

C) Failed to establish Quality agreements with starting materials suppliers

D) Failure to follow the Incident reporting system as per your site SOP.

OBSERVATION 2:

Procedures describing the handling of written and oral complaints related to API Materials are not followed.

A) In adequate closure of market complaint closure without tracking fulfillment.

B) Complaint investigation concluded with CAPA, no CAPA has logged and not implemented the SOP revision.

OBSERVATION 3:

Building used in the manufacturing, processing, packing of API finished materials are not maintained in a good state of repair.

As the facility containment not meeting as required.

OBSERVATION 4:

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of API finished materials prior to release.

OBSERVATION 5:

There is NO assurance that the equipment used in the production of ___ and ___API are always maintained and kept in under proper conditions for manufacturing operations and no prevent the contamination of the products.

A) Failure to fulfil the record sheets as required

B) A piece of fabric thread was observes the inside the filled container

C) Presence of product was observed inside the following production equipment.

CIPLA gets 483 by U.S. FDA For Goa Unit | CIPLA 483 | FDA |

Leo Group India9:35:00 AM2018, 483, cipla, FDA, Mahender, Mar18 No comments

Cipla Ltd. received eight observations regarding manufacturing practices at its Goa plant that contributes a quarter of the drugmaker’s sales in the U.S.

The facility of India’s second-largest pharma company by market value was inspected from Jan. 22 -25, according to a Form 483 issued by the U.S. Food and Drug Administration.

Here are the eight U.S. FDA observations for the Goa plant:

Failure to review out of specification investigation.
Failure of documentation of batch production and control records.
Laboratory records incomplete of all data obtained during testing.
Establishment test procedures are not followed.
No visual examination of reserve samples lots.
Appropriate lab determination of drugs missing.
Quality control procedures are not in writing and fully followed.
Equipment not of appropriate design.

The first observation is a repeat and a little concerning while the others are procedural, said Praful Bohra of brokerage Equirus Capital. Cipla will have to explain to the U.S. FDA the difference in the conclusion tests for the plant to get cleared, he said.

Source: BloombergQuint

SUN Pharma Halol Baroda Gets three Observations | GMP VIOLATIONS | FDA | 483 |

Leo Group India9:10:00 AM2018, 483, FDA, Mahender, Mar18, SUN No comments

SUN Pharma Halol Baroda Gets three Observations | GMP VIOLATIONS | FDA | 2018 |

US FDA has inspected India’s major Drug maker M/s SUN pharmaceuticals dated 12-02-2018 to 23-02-2018 and revealed form 483 with 03 observations.

The observations related to Facility design, written procedures, equipment and cleanliness, according to the U.S. Food and Drug Administration’s Form 483 reviewed by GmpViolations.com

Observation 1:

Separate of defined areas to prevent contamination or mix-ups deficient regarding operations related to aseptic processing of drug products

As inspector has stated that aseptic filling lines showed poor design as the

· Area barriers such as Grade-A and Grade-B has been shown that rough, cracked and uneven surfaces as these rough surfaces may create difficult to clean and leads aseptic area contamination.

· The ceiling above the filling equipment has channels surrounding each of the HEPA filters that are approximately one wide by three inches deep that cannot be accessed with a mop used during cleaning/sanitizing. There is extensive use of sealant around all the HEPA filter units and various rough surfaces on the ceiling such as mounting bolts for the filters that create a difficult-to-clean surface in the Grade-A environment.

· Air-flow visualization studies conducted in April 2017 show upward flow of smoke from below waist level up towards the ceiling return grates of Grade B areas immediately adjacent to Grade A areas. These Grade A areas are used for loading a ___ and filling sterile liquid product vials.

· The Aseptic behavior of personnel not adequate as personnel constant movement with their gloved hands, during machine setup there is no environmental monitoring in place, the selected sampling locations not justified as required.

Observation 2:

Written procedures for cleaning and maintenance fail to include description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance.

· The equipment’s is not installed and maintained according to a written procedures to reduce risk to product contact surfaces or process materials.

· The Inspector has observed that the equipment has labelled as “CLEANED’ however the inspector had found residue on the gasket, torn and degraded style gasket (in adequate PM in place).

· Most of the equipment shown that degraded and dis-coloured gaskets of storage tanks and there is no written procedure in place for replacement of gasket.

Observation 3:

Written procedures are lacking which describe in sufficient detail the sampling, testing, approval and rejection of drug product containers and closures.

· The Cleaning and operation of Vial/Ampoule machine allows the performance of 2 sequential failures without initiation of a deviation investigation. The procedure also states, repeat rejection from the operation as false rejection. (The procedure its influence by-pass the deviations and leads the missing of CAPAs for get rid of re-occurrences)

Best book for knowledge development:

Aurobindo Pharma As Unit 4 Gets Nine Observations | GMP VIOLATIONS | FDA |

Leo Group India10:40:00 AM2018, 483, Aurobindo, FDA, Mahender, Mar18 No comments

Aurobindo Pharma As Unit 4 Gets Nine Observations | GMP VIOLATIONS | FDA |

The observations related to equipment and cleanliness, employees training, quality control and computer controls, according to the U.S. Food and Drug Administration’s Form 483 reviewed by GmpViolations.com

Observation 1:

Aseptic processing areas are deficient regarding system for maintaining any used to control the equipment aseptic conditions?

During inspection the FDA inspector has observed the un-cleaned debris material on the Filling machine and inspector has informed to the respective personnel on the spot, however next day, the same has been observed and filling carried out with dirty equipment (without cleaning).

Observation 2:

Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, Quality or Purity of the drug product.

This can be concluded that the operators are failed to follow c-GMP practices or the written procedures as the Equipment or its utensils must clean and must do follow sanitize in early interval. The Inspector has expected the good aseptic practices and ensure the Product SISPQ.

Observation 3:

Equipment used in the manufacture, processing, packing or holding of Drug products is not appropriate design to facilitate operations for its intended use.

The Vial washer Qualification with inspected Vial presentation not adequate, Example Vial washer failed to demonstrate if vail washer is able to remove bioburden from glass vials that are used for filling. Failed to use statistically sound number of vials to demonstrate the effectiveness of the wash cycle and processes.

“The Batch size selected for cleaning process Qualification is not appropriate as the it was 1% of actual batch size.

“The Batch size selected for endotoxin verification is not appropriate as the it was 1% of a commercial lot size.

Observation 4:

Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.

During Inspector walk-through of the facility a large mosquito has appeared inside the room, semi-finished product storage area holding. This room is located inside the unclassified but controlled environment corridor and is connected sets of doors. This room is two sets of doors away from the grade-B and grade “A” areas where the filling and activities for injection takes place.

Observation 5:

Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

Here it was concluded that failed to demonstrate the efficacy of the cleaning process, which is part of your cleaning activities, to eliminate contaminants in the hard to reach area in the aseptic fill and areas (grade A &B)

Observation 6:

Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.

Observation 7:

The statistical quality control criteria fail to include appropriate acceptance levels and rejection levels.

The procedure for receiving and inspection of the components and packaging materials, (sampling of pacing materials) follows an unspecified level of AQL of with no clear criteria for acceptance and rejection level. This procedure is deficient to provide clear reject and acceptance levels.

Observation 8:

Established laboratory control mechanisms are not followed and documented at the time of performance.

Laboratory control is deficient in that____ USP reference standards, code # with lot #.. used to determine the identity, strength, quality and purity of drug injection which were received in laboratory.

And were not received in laboratory inventory management system (LIMS) as required by your procedure, however they were stored in the same container as other standards which were previously received and were in use.

Were not placed in desiccator as it is recommended on the COA.

Observation 9:

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorised personnel.

Master batch records that are submitted in #___ for __ injection, have different batch codes (document number) than the batch records that are currently in use for commercial production and master batch records that are submitted.

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Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance 1st Edition

FDA has issued warning Letter to Casmara Cosmetics, S.A

Leo Group India8:56:00 AM2018, FDA, Warning Letters No comments

The U.S. Food and Drug Administration (FDA) has inspected drug manufacturing facility, Casmara Cosmetics, S. A., at Calle Ciudad de Lira, No. 29 y 31, Paterna (Valencia), from May 29 to 31, 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 FDA inspection, the investigator has observed specific violations including, but not limited to, the following.

You released your over-the-counter (OTC) drug products, such as (b)(4) lotion and (b)(4), without testing these products for the identity and strength of each active ingredient. Testing your active ingredients is essential to ensuring the drug products you manufacture meet established specifications for the chemical and microbial attributes they purport to possess.

2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to establish the reliability of component supplier analysis on which you rely in lieu of certain tests through appropriate validation of the supplier's test results at appropriate intervals (21 CFR 211.84(d)(l) and (2)).

You failed to test incoming active pharmaceutical ingredients and other components used to manufacture OTC drug products to determine their identity, purity, strength, and other appropriate quality attributes. Instead, your firm relied solely on certificates of analysis from unqualified suppliers.

In addition, you manufacture some of your products using (b)(4), but did not perform an identity test for incoming shipments of this component. You failed to determine whether (b)(4) or (b)(4) was within appropriate limits according to the USP standards for (b)(4). (b)(4) contamination in pharmaceuticals has caused lethal poisoning incidents in humans worldwide.

See FDA's guidance document, Testing of (b)(4) for (b)(4), to help you meet the CGMP requirements when manufacturing drugs containing (b)(4), at (b)(4).

3. Your firm failed to follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Your stability program is inadequate. While you have some data that supports a (b)(4) expiry, this data is insufficient because you failed to include testing for active ingredients. You also failed to demonstrate that the chemical and physical properties of your OTC drug products will remain acceptable throughout the (b)(4) expiry you claim for your products.

4. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

You have not validated the processes used to manufacture your OTC drug products. You did not perform process qualification studies, and lacked an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.

In addition, your batch production records lacked sufficient instructions to ensure reproducibility of your manufacturing processes. Your procedures do not include defined process parameters, such as (b)(4) times, (b)(4)speeds, (b)(4), and bulk hold times. You must have adequate records to document the steps in your manufacturing processes and demonstrate that they remain in control.

Click Here for FDA warning Letter

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

Leo Group India10:31:00 AM2017, FDA, Mahender, OCT17, Warning Letters No comments

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

Source: FDA (Click Here for FDA warning Letter)

www.gmpviolations.com
GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal. (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed/ experts experiences sharing.) Disclaimer: The Logos/Images & content posted here are belongs to respective to Authority / owners of firm. The Article posted under public health importance news. Please ensure the guideline as per Regulatory agencies.

Monday, May 18, 2020

FDA Guideline to 21 CFR PART 211 SUB PART-D EQUIPMENT #21CFR #PART211 #EQUIPMENT #PBS #PBSINDIA

Friday, May 15, 2020

FDA GUIDE TO 21 CFR PART 211 AND SUB PARTS #FDAGUIDE #21CFR #PART211 #FORMULATIONS #GMP #PHARMAGUIDE

FDA GUIDE TO 21 CFR PART 211 AND SUB PARTS #FDAGUIDE #21CFR #PART211 #FORMULATIONS #GMP #PHARMAGUIDE

Sunday, June 24, 2018

Thursday, March 22, 2018

Wednesday, March 21, 2018

Tuesday, March 20, 2018

Tuesday, March 6, 2018

Monday, March 5, 2018

Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance 1st Edition

Sunday, February 25, 2018

Thursday, October 19, 2017

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