Self inspection

The most widely accepted way to identify hazards is to conduct safety and health inspections because the only way to be certain of an actual situation is to look at it directly from time to time. 

Begin a program of self-inspection in your own workplace. Self-inspection is essential if you are to know where probable hazards exist and whether they are under control. 

Don t spend time with items that have no application to your business. Make sure that each item is seen by you or your designee, and leave nothing to memory or chance. Write down what you see or don t see and what you think you should do about it. 

Add information from your completed checklists to injury information, employee information, and process and equipment information to build a foundation to help yon determine what problems exist. Then, as you use the Occupational Safety and Health Administration (OSH A) standards in your problem-solving process, it will be easier for yon to determine the actions needed to solve these problems. 

Once the hazards have been identified, institnte the control procedures described on page 9 and establish your 4-point safety and health program. 

Regular internal audits of GMP operations should be conducted according to an audit master schedule. Records of the findings and any follow-up actions should be maintained. Audits of key suppliers should also be conducted as part of a vendor qualification programme. 

Validation is key to establishing most critical GMP operations. Typical systems that require validation are as follows  

Pharmaceutical sites will usually create a dedicated team of validation specialists to coordinate all validation activities. They should operate according to a validation master plan that has been developed using risk analysis to identify the most critical systems requiring validation/re-validation. Before validating a system or process, a written protocol should be prepared that describes the system, the critical aspects, the objectives, the test methods and the acceptance criteria that will be applied. A validation report should be prepared on completion of each protocol. 

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The facility has a regular self-inspection program utilizing experts from outside the facility or company, in addition to internal personnel. 

Iaing77] Laing, R. Automaton models of reproduction by self-inspection, Journal of Theoretical Biology 66 (1977) 437-456. 

Self-inspection - regular internal auditing and follow up corrective actions... 

There is a procedure for Self-Inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the Quality Assurance system. 

Quality Management Personnel Premises and Equipment Documentation Production Quality Control Contract Manufacture and Analysis Complaints and Product Recall Self Inspection... 

Responsibihties for Production Activities Internal Audits (Self Inspection)... 

Self inspection By the manufacturer of his own processes with appropriate record keeping... 

As shown in Tables 6-8 the Indian GMP regulations consists of eight parts I, IA, IB, IC, ID, IE, IF, and II. Part I covers the general requirements of GMP. It is divided into 29 chapters, which deal with the requirements for personnel, premises, equipment, sanitation, production and process controls, materials, documentation, quality management, validation, reserve samples, recalls, complaints, and self-inspection. Parts IA to IE cover specific requirements for the manufacture of different dosage forms regarding premises, equipment, and methods. Part IA deals with the require-... 

Contract manufacture and analysis Complaints and product recall Self-inspection... 

Quality assurance—organizational independence, staff qualifications, self-inspection program, AQL, change control procedures, documentation and reports, complaint files, awareness of current regulations, statistical concept employed, batch record turnaround time, etc. 

The list of 21 items for the self-inspection program can be reviewed in Safety Digest of Lessons Learned. [9] This practical fist included ... 

Regular inspections and self-inspections and many more details. 

Self-Inspections, Managing Deviations and Continnons Improvement.49... 

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