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Thursday, March 22, 2018

Alembic Pharma gets three observations from US FDA for Gujarat plant


















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
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Wednesday, March 21, 2018

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


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.


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Tuesday, March 20, 2018

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













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



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Saturday, March 10, 2018

FDA Guide to Equipment design, size, and location 211.63



FDA Guide to Equipment design, size, and location 211.63
Subpart D--Equipment

Sec. 211.63 Equipment design, size, and location


Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

In order to properly specify equipment and systems, the pharmaceutical manufacturer needs to identify the manufacturing process. This requires that during the development of the product, the critical quality attributes (CQA) of the product, and the associated critical process parameters (CPP) that directly affect the attributes, be identified and the effort of the parameters on the attributes be understood. These requirements are to be included in a user requirements specification (URS) of the equipment/system. This specification is to focus only on the manufacturing requirements, for example, range of critical processing parameters, sensitivity of the control system to maintain these parameters, and so on. The purpose of this focus is to ensure that the qualification testing is limited only to the equipment capabilities that are required to manufacture an effective product.

In the past it was common to have qualification testing address all equipment’s/system capabilities. However, this type of testing is normally addressed during the start-up and commissioning of the equipment/system. Only capabilities that the manufacturing characteristics are tested during qualification. Therefore, commissioning tests the equipment/system against the requirements of the purchased specification, whereas the qualification testing address those requirements in the URS.

An important tool used during the selection of equipment is to perform an impact assessment. The impact assessment provides a scientific rationale to the effect the equipment system has on the quality attributes of the product being manufactured. The assessment segregates equipment system into three categories: direct impact, indirect impact, and no impact. This categorization enables the appropriate attention to be directed towards the specification, installation, and qualification of equipment system.
Once the use of equipment system has been properly identified, as indicated in the previous edition, several parameters are to be considered when evaluating the equipment:

1.   Availability of spares and servicing

2.   The frequency and ease of maintenance will significantly impact on productivity and even quality. Equipment breakdown during processing could adversely affect quality. Included in the maintenance evaluation should be the cleanability of the equipment. This will involve accessibility to the parts to be cleaned and the relative ease of disassembly.

3.   Environmental issues are important constructions. Is the design of the equipment conducive to the application? Such attributes as the ability to contain toxic products, the ability to contain dust, the ability to maintain aseptic conditions, etc. need to be reviewed.

4.   Construction materials and design (see 211.65)

5.   The type of process controls such as automatic weight adjustment on tablet presses and temperature recorders on ovens. The use of these controls has become a routine and is expected in today’s manufacturing environment. The PAT initiative depends upon these controls to demonstrate that the manufacturing process is under control and to facilitate a continuous improvement program.

New equipment should not be used for commercial production until it has been qualified and the proceeds in which it is to be used has been validated; this applies equally to laboratory and other test equipment. All equipment should be appropriately identified with a unique number, to allow reference in maintenance programs and in batch records (see also 211.105(a)).

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The location of the equipment in the facility must enable an efficient flow of the manufacturing process. Manufacturing trains should be uni-directional whenever feasible. Back flow or cross flow within the process are to be minimised, as these incidences inherently have a high capability to cause mistakes.

The equipment system is to be placed in such a manner so as to enable all parts requiring maintenance, instrumentation, and calibration to be easily accessible. The key is easily accessible. Locating equipment in areas that are inaccessible usually means the maintenance and cleaning operational are not performed adequately, and thus leads to errors during the manufacturing of products.

References: 

FDA

Good Manufacturing Practices for Pharmaceuticals, Sixth Edition edited by Joseph D. Nally


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Wednesday, March 7, 2018

FDA GUIDE TO Personnel responsibilities. 211.28



Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination it’s include primary garments secondary garments and if applicable sterile garments shall be in place as necessary to protect drug products from contamination.

Personnel shall practice good sanitation and health habits.

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Only personnel authorised by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas.
Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

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Tuesday, March 6, 2018

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


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)
     
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Monday, March 5, 2018

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
















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
















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