annual review 产品质量年度回顾英文版模板

1.0PURPOSE:

To perform the annual review of complaints, recalls, returned or salvaged drug products,

notification of rejection forms, out of specification result forms, critical system change control

forms, investigation/deviation report forms, product specifications, manufacturing and control

procedures.

2.0 SCOPE:

2.1All Customer complaints, recalls, returned or salvaged drug products, notification of

rejection forms, out of specification result forms, critical system change control forms,

investigation/deviation reports that occurred throughout the year will be reviewed on an

annual basis.

2.2Applies to all products and the documents pertaining to their manufacture.

3.0 RESPONSIBILITY:

3.1 It is the responsibility of the Quality Control/Stability Systems Technician to prepare a

separate annual report on each product that is marketed by Company.

3.2 The Quality Assurance Assistant Scientist and/or the QA Manager is responsible for

reviewing the documentation from selected batches of every product.

3.3 The QA/QC Director and/or the QA Manager and/or QC Manager are responsible for:

3.3.1 Reviewing each products annual report.

3.3.2Perform review of recalls, returned or salvaged drug products, notification of

rejection forms, out of specification result forms, critical system change control

forms, investigation/deviation report forms.

3.4The Regulatory Affairs Paralegal is responsible for providing a summary annual review

report of all complaints by product.

3.5The Regulatory Affairs Director is responsible for reviewing the summary annual

complaint report.

3.6 The QA/QC Director is responsible for notifying the responsible officials of the company

in writing if an investigation is performed on Returned Drug products or on Drug Products

that are salvaged because of improper storage conditions.

4.0 PROCEDURE:

SOP

Supersedes: 11/8/01 DBC: 6.17

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4.1 The records associated with a selected batch/lot of finished product for each bulk formula,

including all raw material and packaging material records that are used to manufacture and

package the batch/lot of product are reviewed for content and completeness annually.

4.2The records for complaints, recalls, returned or salvaged drug products, notification of

rejection forms, out of specification result forms, critical system change control forms and

investigation/deviation reports are reviewed. The annual review file contains the QC

review results summarized by product, QA results summarized for each bulk formulation,

and the Regulatory Affairs results summarized by product.

4.2.1The Regulatory Affairs Paralegal will log all complaints for each product on a list,

indicating the type of complaint, it’s frequency and any trends noted. This list is

reviewed by the Regulatory Affairs Director to determine any significant changes

in frequency or type of complaint for each product from previous years.

4.2.2The causes for any recalls will be examined and an investigation will be performed

to assure all corrections were made to the reason for the recall. The report of the

investigation is issued to the responsible officials of the company.

4.2.3The returned goods policy is reviewed for content and implementation. The

returned goods reports are reviewed to assure completeness and accuracy. Any

necessary changes will be made as required. If an investigation is required, the

responsible officials of the company will be notified.

4.2.4Notification of Rejection Forms are reviewed and summarized for trends.

4.2.5Critical System Change Control forms are reviewed for completeness.

4.2.6Out of Specification Result Forms are reviewed and summarized for trends.

4.2.7Investigation/Deviation Reports are reviewed to determine any trends.

Recommendations for improvement in an area will be given to the correct

department manager.

4.3 Each product’s annual report, which contains the following, is r eviewed:

4.3.1 Stability Assay test results are recorded for each product on a yearly basis. The

data is reviewed throughout the shelf life of the product. If a product has no

expiration date then results are recorded for at least 48 months and reviewed.

4.3.2 Quality Control test results for each batch are reviewed for each product. The data

are tabulated in an Excel spreadsheet and a summary is generated for each product.

4.4 Product specifications, Product Control Procedures, the current Formula and the

Manufacturing Procedures are updated as needed based on the annual review.

SOP

Supersedes: 11/8/01 DBC: 6.17

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4.5 The annual review is documented and

filed.

SOP

Supersedes: 11/8/01 DBC: 6.17

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