- OBJECTIVE
To lay down a procedure to review and evaluate the need for any change required and /or to review any change which has already taken place in API and drug product specifications and /or manufacturing and control procedures.
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- RESPONSIBILITY
- Executive – QA shall be responsible for collection of the data and their trends.
- In-charge – Quality Assurance shall be responsible for review of the parameters.
- Head-Production, Head-Quality Control, Head-Engineering and Head -Quality shall be responsible for approval.
- PROCEDURE
- Annual Product review shall be carried out for each product manufactured for commercial purpose in the previous calendar year (January to December) and implementation of preceding year’s recommendations shall be reviewed. The APR shall be prepared based on the following criterias:-
3.1.1 The APR shall be prepared product wise including the brand name for a single customer, which are supplied to different markets in case of Regulated markets.
3.1.2 The APR shall be prepared on generic name for all other markets (ROW markets).
- The final annual report shall be available within 60 days after the end of the calendar year. The following data and/or information shall be collected, summarized and reviewed for:
- Brief description of the product and total number of batches manufactured, released and rejected during the review period.
- Current manufacturing formula, brief description of manufacturing process and flow chart of current manufacturing process and packing (Give reference of Current MFC No).
- Details of primary packing materials, critical testing parameters and packing instructions.
Source of starting materials, Packing materials has to be reviewed for ensuring the usage of materials as per source specified in the Marketing Authorisation and to review the suppliers of active ingredients have been audited to ensure the suppliers are comply with GMP.
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- Total number of batches manufactured, API used in the respective batches and its Analytical results of API (Assay, Water content/LOD, Particle size distribution and Related Substances) used in the respective batches.
- Yield at different Stages of manufacturing (Blending, Compression, Coating, inspection, Capsulation, Filling, Packing) shall be reviewed and trended.
- Results of all critical In-process parameters (as applicable), at different stages of manufacturing as mentioned below, (the review of the parameters listed below may vary depending upon the product under consideration).
- Dry mixing / wet Granulation stage – % reading of Impeller and Chopper
- Drying stage – LOD / Water content
- Compression stage – Group weight, Individual weight, Hardness, Thickness, Friability, Disintegration test.
- Coating – Inlet temperature, Outlet temperature, Individual weight, Group weight, Thickness.
- Capsulation stage – Group weight, individual weight, lock length, Disintegration test
- Bottle filling – Uniformity of weight
- Dry powder injection – Fill weight
- Lyophilization – pH, Individual Fill volume
- All the key Analytical (Micro and Chemical) parameters (as applicable) of semi finished and finished product shall be reviewed and trended as mentioned below, (the review of the parameters listed below may vary depending upon the product under consideration).
- Blend: Assay, LOD / water content.
- Core / Coated tablets: Average weight, Uniformity of dosage units, Thickness, Water content, Assay, dissolution, Total related substances.
- Capsules: Average fill weight , Uniformity of dosage unit , Dissolution , Assay, water content , Total Related substance, Disintegration, Lock length.
- Orals Suspension / Drops: Average weight, Fill weight variation, Water content , Assay , Specific gravity , pH, Uniformity of dosage , Dissolution, Total Related substance ,Viscosity , microbial limit (initial day and final day analytical results shall be reviewed).
- Dry Powder Injectable: BET, Uniformity of dosage units , pH , Water, Particulate Matter, Assay , Total Related substance.
- Bulk solution: Assay, pH, Weight per ml, Microbial Count.
- Lyophilized Vials: Assay, Average fill weight, uniformity of dosage units, BET, pH, water content, Extractable volume, Reconstitution time, Total related substances.
- Validation batches during the review period shall be indicated and results of validation studies and any qualification activities associated with critical equipments, facilities and utilities shall be reviewed.
- Approved changes requests with respect to the product shall be reviewed.
- All the stability studies initiated during the review period and reasons for study shall be reviewed and listed.
- Deviations / (Exception) / Non conformances associated with the product during the review period shall be reviewed and listed the Investigations carried out, and corrective and preventive actions were introduced to prevent reoccurrence.
- Out of specifications (if any) its reason and investigation details shall be summarized.
- Corrective and preventive action (CAPA) programmes introduced were reviewed for the appropriateness to resolve the problems and to introduce further changes.
- Visual inspection reports of control samples shall be reviewed.
- Product complaints received, investigated and closed out during the reviewed period shall be summarized by preparing the trends and reviewed for implementation of changes to prevent reoccurrence.
- Product recalls, field alert or returned during the review period shall be summarized by preparing the trends and reviewed for implementation of changes to prevent reoccurrence.
- Variations submitted, status of the approval and refused shall be reviewed during the review period and listed the reasons for rejection.
- Post marketing commitments, which have given to Regulatory authorities during the filings, shall be reviewed for any further information when available like ongoing stability data, validation data and finished product samples etc.
- Ensure the availability of Technical Agreements between all the suppliers (Contract Acceptor) and contractors (Contract Giver) and reviewed the adequate activities and responsibilities of each party were meeting the GMP guideline reflecting in the Technical Agreements.
- Each set of data available shall be tabulated and/or graphed in such a fashion so as to easily exhibit results, deviations and trends.
- The data collected for the parameters , shall be subjected to statistical analysis (as applicable), LCL (Lower control limit) & UCL (Upper control limit) shall be calculated using the formula : X ± 3 σ ( Where X = Average of data , σ = Standard deviation ). The same shall be included in trend chart (if applicable).
- Each section listed above shall be summarized to include any recommendations or actions plans to address concerns or issues noted.
- A statement indicating the conclusions of the individual APR such as Process in –control, actions recommended, corrective actions required shall be included.
- Status of any action plans from previous APRs for this product shall also be considered.
- The completed APR shall be reviewed by QA –In charge and approved by the following:
- Head – Production
- Head – Quality Control
- Head – Engineering
- Head – Quality
3.9 After completion a copy shall be submitted to Qualified Person for review and signed off. One signed copy shall be submit to contract giver incase of contract manufacturing products.
4 ABBREVIATIONS
4.1 QA – Quality Assurance
4.2 RA – Regulatory Affairs
4.3 APR – Annual product Review
4.4 MFC – Master formula card
4.5 MPC – Master packing card
4.6 GMP – Good manufacturing practice
- REFERENCES
Not Applicable
- ANNEXURES
Not Applicable