Current Good Manufacturing Practices

Inspection

Posted on June 12, 2008. Filed under: CGMP | Tags: Inspection, Inspectors, Types of Inspection |

Inspection

Prof. Manohar A. Potdar

Head of Quality Assurance Department, Poona College of Pharmacy, Pune, India

potdar_manohar@yahoo.com.au

Supriya Sharma, Shamita Kohli
Poona College of Pharmacy, Bharati Vidyapeeth University, Pune, India

 

Inspection means the control and enforces compliance with general Good Manufacturing Practices or we can say to authorize the manufacture of specific pharmaceutical products normally in response to a licensing application.

            In pharmaceutical field the inspection of manufacturing & Quality Control facilities are to be done prior to marketing authorization for the product to be granted.

            Inspector may be the independent person or a group of person who review the quality system of a company in compliance with the standards issued by the International Organization for Standardization (ISO 9000-9004) or British Standards Institution (BS 5750) with other equivalent National Standards.

 

Basic requirements for the Inspector:

Inspector should have previous training and practical experience in the manufacture and Quality Control of pharmaceutical product. Inspector should be graduate Pharmacist, Chemist or Scientist with an industrial background in pharmaceutical product. In-post training should include an element of apprenticeship gained by accompanying experienced inspectors on site visits as well as participation in courses and seminars on relevant subjects including modern pharmaceutical technology, microbiology, and the statistical aspects of quality control.

 

The inspector should have the following attributes:

 

·      good knowledge of pharmacy, drugs, and poisons

·      good knowledge of the laws and regulations to be enforced

·      good command of technical terms and excellent communication skills

·      awareness of the probable methods of using forged or false documents for transactions in pharmaceutical preparations and skill in determining the genuineness of documents presented for examination

·      maturity, honesty and integrity

·      responsible conduct which commands respect

·      willingness to accept challenges

·      ability to organize their own work with minimum supervision

·      ability to assess facts quickly and take rational and sound decisions without delay

·      ability to assess character and honesty of persons being interviewed

·      good public relations image with key personnel/pharmacists in charge of premises while remaining firm, fair and resolute

·      ability to hold discussions with company management at the completion of inspection

·      ability to motivate others

·      commitment to hard work and long hours

·      ethical approach to any potential conflict of interest.

 

Inspector’s requirements

Good Inspector

 

Experience concerning usage and quality problems

 

Good communication with staff of all levels

 

Experience of the components manufacturing process

 

Full understanding of G.M.P. & legal requirements

 

Familiar with general manufacturing standards operated in industry concerned

 

Prepare in advance of visit

 

Realistic prepared to listen

 

 

 

 

 

 

Responsibilities of an Inspector:

An inspector should present a detailed factual report on standards of manufacture and control applied to specific products. However, inspection should not be limited to compilation of an inventory of faults, irregularities, and discrepancies. Provided it is in keeping with national policy and does not breach understandings regarding confidentiality of information having commercial value, advice may be offered on how production and control procedures can be usefully upgraded. An inspector should always be expected, to offer advice on how to improve an in-process test procedure or to offer other assistance which, in his or her opinion. An inspection should be regarded as an opportunity to assist and motivate a manufacturer to comply with GMP and to correct any specific deficiencies.

 

Types of inspections:

 

Routine inspection

This is a full inspection of all relevant components of GMP and licensing requirements. It may be indicated when the manufacturer is newly established or requests the renewal of a license or he  has introduced a new product, or has made a significant modifications to  the manufacturing methods or has made some changes in key personnel, premises, equipment, etc.;

 

Concise inspection

Manufacturers with reliable records of compliance with GMP in the course of previous routine inspections are appropriate for concise inspection. The heart of a concise inspection is on a partial number of GMP requirements chosen as indicators of overall GMP recital, with respect to the identification of any noteworthy changes that could have been introduced since the last inspection. Cooperatively, the information obtained will indicate the overall attitude of the firm towards GMP. Evidence of unsatisfactory GMP recital observed throughout a concise inspection should set off a more comprehensive inspection.

 

Special inspection

Special inspection are generally carried by visits which may be essential to carry out spot checks for following complaints or recalls associated to supposed quality defects in products. Reports of adverse drug reactions may also point out that all is not well. Such inspections may be focused on one product, a group of related products, or specific operations such as mixing, sterilization, or labelling. Special visits may also be made to set up how a specific product is manufactured as a precondition for marketing approval or issuance of an export certificate. A supplementary reason for special visits is to congregate specific information on or to investigate specific operations and to advise the manufacturer of regulatory requirements.

 

Inspection procedures

 

 The GMP inspectorate should have the necessary resources such as financial, human, facilities and documented procedures to allow the inspection of manufacturing operations to be carried out in accordance with the general requirements of the WHO guidelines on GMP and/or the national GMP guidelines. The GMP inspectorate should require the manufacturer to have documented procedures in accordance with a quality management system, and complying with the WHO guidelines on GMP and/or the national GMP guidelines. The GMP inspectorate should perform regular inspections of the manufacturing premises, procedures and quality systems of authorization holders at least once every 2 years in accordance with a written inspection programme. Written inspection reports should be prepared and sent to the national regulatory authority to keep it informed of the outcome of such inspections. The arrangement of inspections of manufacturers and the evaluation of compliance with the planning concerning the performance of the different types of inspections should be documented. The types of inspections should include as a minimum routine inspections, specific inspections, follow-up inspections and concise inspections.  

 

 INSPECTION

 

 The activities relating to post-marketing surveillance and product testing should be described. The description should also cover the process of handling non-conforming products (e.g. substandard or counterfeit products). The procedure for operations in support of a surveillance sampling programme should be documented. The GMP inspectorate should have the documented procedures and resources to enable the inspection of manufacturing and wholesale distribution operations to be carried out in accordance with the official guidelines and national legislation. A formal inspection plan should be followed. All instructions, standards or written procedures, worksheets, checklists and reference data relevant to the work of the GMP inspectorate should be kept up to date and be readily available to staff. A chief inspector should be appointed to coordinate inspection activities if more than one inspector is involved in an inspection. The lead inspector, who should be selected by all the participating inspectors, should normally prepare the inspection report. Observations and/or data obtained in the course of inspections should be recorded in a timely manner to prevent loss of relevant information.  Completed inspections should be reviewed to ensure that the requirements have been met.

 

Carrying out the inspection

 

Emphasis should be positioned on the assessment of the manufacturing procedure, together with the data verification and the measurement of compliance with GMP. The production and control procedures described in the application must be compared with those of used for the make of pre-approval batches. If warranted by records of past label mix-ups, packaging and labelling control procedures should be evaluated. A programme of ongoing stability testing needs to be addressed.

The inspection team will determine whether the application provides the scientific data justifying full-scale production procedures and controls. The validation of pertinent manufacturing procedures, including equipment qualification, will also be evaluated. However, inspectors should not suggest withholding endorsement of applications based on be short of of complete full-scale, multiple-batch validation of sterile and non-sterile processes, except the data submitted in the application are found to be of doubtful validity or entirety. It should be understood that full-scale validation may be done after endorsement of the application, but previous to consignment of the first profitable batches. Yet, convinced data must be built-in the application to reveal that the sterilization or aseptic fill procedure has been qualified. The inspection team is anticipated to audit the data to resolve their genuineness, accuracy and entirety. Tentative products are frequently produced in facilities other than those used for full-scale production. These facilities and the related manufacturing and control procedures are not habitually inspected except validation of the transfer of the methods from the “investigational” facilities to the full-scale facilities is deficient or doubtful. The facilities may be periodically inspected when this is required by national legislation/regulation.

Generally inspection is carried out for Quality Management System, Production, Quality Assurance and Quality Control, Premises and Equipment, Utilities, Safety, Complaints and Product Recall etc. Basic principles of GMP like Training, documentation, authorized release, etc should be the main criteria for the inspection.

 

What the inspector expect and keep in his mind during his inspection according to W.H.O. and how we can prepare for the same?

There are following things in the mind of inspector. These are classified section wise as follows:

 

 

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