1. Is the area equipped to avoid cross-contamination and physically separated from the other rooms by walls or other type of separation? 2. Are lighting and ventilation adequate? 3. Is there temperature and humidity control, where required? 4. Are weighing and dispensing area maintained in a clean ...

Objective To provide a procedure to audit a new vendor or re-audit an existing vendor for the active / inactive ingredients and packaging materials. Scope This procedure is applicable for approval of all vendors (manufacturers) and suppliers of incoming Active Pharmaceuticals Ingredients (APIs), Inactive ...

GMP audit of any pharmaceutical industry is very important and crucial in its business. Therefore, before the audit, the preparation of the audit must be done properly. We can plan any GMP audit in following way: 1. Review documents 2. Prepare audit plan 3. Key persons 4. Audit responsibilities 5. Internal ...

The main objective of an internal audit assignment is to evaluate and, if necessary, improve through recommendations, the effectiveness of internal business controls, risk management plans and overall business processes. A typical audit procedure begins by evaluating current processes and procedures. ...

Personnel =>> Is up-dated organization chart showing an arrangement for quality assurance including production and quality control available? =>> Is updated technical staff list is available with the following information – Name, qualification and years of relevant experience of responsible pharmacists, ...

1. Do the packaging operations proceed following the instructions and using the specified materials described in the Master Packaging Procedure? 2. Are the details of the operation recorded on the Batch Packaging Record? 3. Is only one product batch and packaging size on a line at any given time? 4. ...

1. Is validation, properly done to all critical production procedures? (Indicate all critical production procedures for which validation is done? a. conducted in accordance with previously defined procedures? b. result maintained? c. extension and degree dependable on the value and complexity of the ...

1. Is high level of sanitation and hygiene implemented in every aspect of manufacturing of drug product? 2. Are protective measures taken to avoid direct contact of operators and materials (raw materials and drug products) and assuring protection of product from contamination as well as the safety of ...

1. Is brief description of major production and quality control lab. Equipment indicating construction, validation and suitability of other materials (polypropylene, chrome plated brass, PVC, non-reactive plastic materials) provided? 2. Are the equipment of appropriate design, construction and adequate ...

Internal auditing programs are critical to monitoring and ensuring that all of your business assets are properly protected and protected from threats. It is also important to verify that your business processes reflect your documented policies and procedures Let’s look at five reasons why internal ...