Process Validation Report in Pharmaceutical Industry

PPQ Protocol Execution and Report

Execution of the PPQ protocol should not begin until the protocol has been reviewed and

approved by all appropriate departments, including the quality unit. Any departures from the

protocol must be made according to established procedure or provisions in the protocol. Such

departures must be justified and approved by all appropriate departments and the quality unit

before implementation (§ 211.100).

The commercial manufacturing process and routine procedures must be followed during PPQ

protocol execution (§§ 211.100(b)

and 211.110(a)). The PPQ lots should be manufactured under normal conditions by the personnel routinely expected to perform each step of each unit

operation in the process. Normal operating conditions should include the utility systems (e.g., air handling and water purification), material, personnel, environment,

and manufacturing procedures.

A report documenting and assessing adherence to the written PPQ protocol should be prepared in a timely manner after the completion of the protocol. This report should:

•Discuss and cross-reference all aspects of the protocol.

•Summarize data collected and analyze the data, as specified by the protocol

Contains Nonbinding Recommendations

•Evaluate any unexpected observations and additional data not specified in the protocol.

•Summarize and discuss all manufacturing non conformances such as deviations,

aberrant test results, or other information that has bearing on the validity of the

process.

•Describe in sufficient detail any corrective actions or changes that should be made to existing procedures and controls.

•State a clear conclusion as to whether the data indicates the process met the

conditions established in the protocol and whether the process is considered to be in a state of control. If not, the report should state what should be accomplished before

such a conclusion can be reached. This conclusion should be based on a documented justification for the approval of the process, and release of lots produced by it to the market in consideration of the entire compilation of knowledge and information gained from the design stage through the process qualification stage.

•Include all appropriate department and quality unit review and approvals.